HONG KONG, Mar 25, 2022 - (ACN Newswire) - Kindstar Globalgene Technology, Inc. ("Kindstar Globalgene" or the "Company", together with its subsidiaries, collectively the "Group"; stock code: 9960.HK), a leading independent esoteric clinical testing service provider in China, today announced its audited annual results for the year ended 31 December 2021 ("2021" or the "Year").
During the period under review, the Group recorded total revenue of RMB930.67 million, representing a year-on-year increase of 4.4%. Revenue from non-COVID-19-related testing services was RMB868.57 million, an increase of 12.3%. The Group's consolidated gross profit was up by 5.4% year-on-year to RMB485.77 million, while the consolidated gross profit margin rose by 0.5% year-on-year to 52.2%. Cash and cash equivalents amounted to RMB1,796.7 million, a growth of 113.6% year-on-year. The non-COVID-19-related testing services segment recorded results of RMB197.18 million, an increase of 17.5% year-on-year. The Board has resolved not to distribute a dividend for FY2021.
Focused on specialty esoteric testing services and vigorously developed related services in six major specialty areas
Since its inception in 2003, the Group has been focusing on esoteric clinical testing services and is one of the first companies in China entering the esoteric testing service industry. During the period under review, the Group covered more than 3000 hospitals, in which over 60% are Class III hospitals, added three new laboratories and its esoteric testing volume exceeded 1.68 million, with positive growth in all six major esoteric testing specialty areas.
-- Hematology testing: The Group introduced 50 new testing items and added the Shanghai Xinnuo Baishi Medical Laboratory. During the period, the Group achieved revenue of RMB535.27 million and segment results of RMB152.57 million, representing a year-on-year increase of 14% and 15.7%, respectively. -- Neurology testing: The Group launched six new projects covering diseases such as Alzheimer's disease and myasthenia [gravis] and also added 143 partnering Class III hospitals. The Group recorded revenue of RMB89.85 million and segment results of RMB14.06 million during the period, a year-on-year increase of 18.2 and 11.6%, respectively. -- Maternity-related testing: The Group added the diagnosis of gestational syndromes during the period, and recorded revenue of RMB52.25 million and segment results of RMB3.55 million, representing a year-on-year increase of 0.2% and 0.5%, respectively. -- Genetic disease and rare disease testing: During the period, the Group realized revenue of RMB43.50 million and segment results of RMB5.43 million, representing a year-on-year increase of 20.2% and 126.4%, respectively. Sales of multiple steroid hormone tests doubled year-on-year. -- Infectious disease testing: The Group introduced 28 new testing items and added the Wuhan Kindstar Zhenyuan Medical Laboratory, achieving revenue of RMB51.97 million and segment results of [RMB]9.78 million during the period, representing a year-on-year increase of 3% and 33.2%, respectively. -- Oncology testing: The Group launched new testing service items for various types of cancer, including intestinal cancer, cervical cancer, bladder cancer and liver cancer, achieving revenue of RMB8.62 million and segment results of RMB0.83 million during the period, 13.4% and 82.5% higher than the same period last year. -- Others: The Group added more than 20 scientific research service projects in the areas of research services, CRO and new testing services, achieving revenue of RMB19.46 million and segment results of RMB5.99 million during the period, representing a year-on-year growth of 36.1% and 35.1%, respectively.
Persistent R&D investment to develop and expand new specialty esoteric testing business lines
As at 31 December 2021, the Group's R&D expenses amounted to RMB90.33 million, a year-on-year increase of 20.0%.The Group had 112 new R&D projects, 17 patents were pending or granted and 23 scientific research articles were published throughout the year. During the period under review, the Group stepped up its efforts in promoting the development of specialty esoteric testing services in China and expanding the scope of such services to cover cardiovascular diseases, ophthalmology, rheumatology and immunology.
-- Cardiovascular diseases: The Group focused on the R&D of biomarkers for cardiovascular diseases such as coronary heart disease, acute myocarditis and acute myocardial infarction. It also conducted verification studies on the clinical value of biomarkers. -- Ophthalmology: The Group actively explored opportunities in ophthalmic structured esoteric testing services and its R&D covered testing solutions for hereditary oculopathy, infectious oculopathy and autoimmune oculopathy. -- Rheumatology and immunology: The Group began the initial development of six types of disease and drug detection projects, covering sicca syndrome, rheumatoid arthritis, ankylosing spondylitis, gout, antiphospholipid syndrome and allopurinol detection.
Entered the IVD reagents field and optimized immune repertoire deployment
Wuhan Haixi Life Science Technology Co., Ltd., which the group owns a controlling stake, is a high-tech enterprise based on the R&D, manufacturing and sales of esoteric testing reagents providing systematic, comprehensive "high-precision and cutting edge" testing reagent products. The Group's main products, namely reagent kits for JAK2 genes and V617F mutations (PCR-fluorescent probe method) and reagent kits for leukemia fusion genes qualitative testing (PCR-fluorescent probe method) will enter the clinical trial stage of NMPA registration. During the period under review, the Group established its business presence in the field of IVD reagent kits in the upstream industry chain by holding shares in Wuhan Haixi Life Science Technology Co., Ltd.
As an important next-generation sequencing technology, the immune repertoire sequencing technology may bring disruptive changes to the industry in the future. During the period under review, the Group established Wuhan Kindstar Biotechnology Co., Ltd., which will focus on the application and development of the immune repertoire technology in multiple disciplines and explore the biopharmaceutical and immunotherapy pathways. In addition, to further improve its immune repertoire layout, the Group invested in Shenzhen Neoimmune Co., Ltd., a leading immune repertoire enterprise in China. Looking ahead, the two parties will commence strategic cooperation in the immune repertoire segment.
Strategy and Prospects
The Group will continue to consolidate its leading position in esoteric hematology testing in China and replicate its successful experience in hematology to expedite the growth of its specialty esoteric testing business in areas such as genetic diseases, rare diseases, infectious diseases, oncology and neurology. In the next three to five years, the Group will enter several new areas of specialty esoteric testing. At the same time, the Group is also committed to building strong relationships with a wide range of participants in the clinical esoteric testing industry (including doctors, hospitals, pharmaceutical companies, contract research institutions, academic institutions and regulatory agencies), deepening existing strategic partnerships, and expanding the existing cooperation network. Since its listing, the Group has attached great importance to opportunities for horizontal and vertical integration in the industrial chain. In the future, the Group will steadily achieve a strategic and forward-looking layout through investment, integration and empowerment, in order to boost its growth.
Huang Shiang, Chairman and Chief Executive Officer of Kindstar Globalgene, expressed full confidence in the future of China's esoteric clinical testing industry. He said, "Due to increasing public health awareness and an aging population in China, the demand for clinical tests has continued to increase. In recent years, China's esoteric clinical testing market has been growing faster than its routine testing market, and the Company has strived to develop and introduce advanced technologies to meet the enormous unmet medical demand in the country. Looking ahead, we will actively overcome the various uncertainties caused by the COVID-19 pandemic, while continuing to work hard to maintain the steady growth of our existing esoteric clinical tests, and develop and launch new services in specialty areas, thereby contributing to the precise diagnosis and advancement of treatments in specialty areas in China."
About Kindstar Globalgene Technology, Inc. Kindstar Globalgene Technology, Inc. ("Kindstar Globalgene" or the "Group"; stock code: 9960.HK) is a leading independent esoteric clinical testing service provider and a major provider of hematology esoteric testing services in China. It has built a comprehensive testing portfolio, a broad hospital network and advanced technology platforms and also boasts the largest esoteric testing portfolio among all independent esoteric testing providers in China, with more than 3,500 tests on its service menu and offering one of the most extensive hematology testing portfolios worldwide, including over 2,300 testing items in the field. The Group primarily targets specialty areas with substantial growth potential or that can create significant synergies with its esoteric hematology testing services, including genetic diseases and rare diseases, infectious diseases, oncology and neurology. The Group was listed on the Main Board of the Hong Kong Stock Exchange on 16 July 2021. Over the past 18 years, the Company has developed more than 1,100 testing items entirely in-house, and introduced approximately 2,400 testing items developed by or under license from third parties. The Group serves more than 3,000 hospitals in China, of which more than 1,500 are Class III hospitals, including all of the top 20 hospitals in the nation. The Group's mission is to offer a broad range of high-quality specialty testing services to patients and physicians worldwide, and to promote the application of precision diagnostics and medicine.
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comKindstar Globalgene Technology, Inc. ("Kindstar Globalgene" or the "Company", together with its subsidiaries, collectively the "Group"; stock code: 9960.HK), a leading independent esoteric clinical testing service provider in China, today announced its audited annual results for the year ended 31 December 2021 ("2021" or the "Year").
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HONG KONG, Mar 22, 2022 - (ACN Newswire) - Essex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the annual results for the year ended 31 December 2021.
Highlights -- The group's turnover surged 67.4% to HK$1,637.7 million, Profit-After-Tax lifted 58% to HK$346.0 million;
-- Sales coverage increased to around 10,500 hospitals and 2,110 pharmaceutical stores in the PRC;
-- Obtained an approval for the registration and commercialisation of the preservative-free unit-dose Moxifloxacin Hydrochloride Eye Drops in the PRC;
-- Significant progress in R&D program, 15 R&D programs in the pre-clinical to clinical stage, out of which 3 ophthalmology programs are in clinical stage as the below: SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021; Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC); Bevacizumab intravitreal injection for wet-AMD, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC);
-- Holds a total of 44 patent certificates or authorisation letters: 35 invention patents, 4 utility model patents and 5 design patents;
-- Completed the acquisition of IP rights relating to R&D, production and MAH of Shilishun Iodized Lecithin Capsules.
Significant progression in Financial Performances
Essex achieved significant progression and encouraging performances amid the COVID-19 pandemic and macro uncertainties. For the year ended 31 December 2021, the Group recorded a turnover growth of 67.4% to approximately HK$1,637.7 million as compared to approximately HK$978.1 million in 2020, indicating a strong recovery to the pre-COVID-19 operating level. In tandem with the increase of turnover, the Group achieved an increase of 58% in after-tax profit to approximately HK$346.0 million as compared to approximately HK$218.9 million in 2020.
Turnover of Ophthalmology and Surgical Segments Surged 60.6% and 72.6% respectively The Group's turnover is primarily made up from the segments of Ophthalmology and Surgical (wound care and healing). The core products that are of current growth driver under each segment are:
1. Ophthalmology - Beifushu series (Beifushu eye drops, Beifushu eye gel and Beifushu unit-dose eye drops), Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Moxifloxacin Hydrochloride Eye Drops and Shilishun(Iodized Lecithin Capsules); and
2. Surgical (Wound care and healing) - Beifuji series (Beifuji spray, Beifuji lyophilised powder and Beifuxin gel), Carisolv dental caries removal gel, Dr. YaDian mouth wash and Yi Xue An Granules.
The sectoral turnover of Ophthalmology and Surgical is approximately 41.1% and 58.9% of the Group's turnover, respectively. The combined turnover of the Group's flagship biologics, Beifushu series and Beifuji series, the basic fibroblast growth factor (bFGF) based biologic drugs, represented about 84.3% of the Group's total turnover, of which Beifushu series and Beifuji series accounted for 26.1% and 58.2% of the Group's turnover, respectively. The remaining 15.7% of the Group's turnover is mainly contributed from sales of Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Moxifloxacin Hydrochloride Eye Drops, Shilishun Iodized Lecithin Capsules, Carisolv dental caries removal gel, Dr. YaDian mouth wash and Yi Xue An Granules, collectively. Ophthalmology segment contributed approximately HK$673.3 million to the Group's turnover for the year ended 31 December 2021, representing an increase of 60.6% as compared to approximately HK$419.2 million in 2020. Surgical segment recorded a total turnover of approximately HK$964.4 million for the year ended 31 December 2021, representing an increase of 72.6% as compared to approximately HK$558.9 million in 2020. The increase was attributable to the resumption of clinical operations in hospitals to normalcy in the PRC and the expansion of sales.
The selling of Xalatan Eye Drops and Xalacom Eye Drops would be discontinued in 2022 that contributed approximately 2% to the Group's gross profit for the year ended 31 December 2021.
The Board proposed a final dividend of HK$0.055 (2020: HK$0.05) per ordinary share to be approved at the upcoming annual general meeting of the Company.
Mr. Patrick Ngiam, Chairman of Essex, said, "2021 has been a year full of diverse challenges. Our part of the world has been affected by extended lockdowns and border closures under COVID zero regime, even as other regions begun to reopen. Despite yet another difficult year inflicted by the pandemic of COVID-19 on us all, the tenacity, drive and leadership in our DNA was able to deliver greater stakeholder value. The Group has achieved significantly improved financial performances in the financial year ended 31 December 2021. This is a testament that the Group's business is resilient and was able to recover swiftly to the pre-COVID-19 level after the normalcy of the clinical operations of hospitals resumed in the PRC since September 2020."
Significant Business Development Activities
The Group is committed to pragmatically investing in new products and technologies to strengthen the Group's product and R&D pipeline as near to mid-term growth driver in ophthalmology and long-term plan for new therapeutics in oncology. During the year under review, major investments in ophthalmic products are outlined as follows:
Investment in Ophthalmology
Significant progress for SkQ1's second phase 3 clinical trial In 2018, the Group entered into a co-development agreement with Mitotech S.A. ("Mitotech") and Mitotech LLC for the United States Food and Drug Administration (the "US FDA") phase 3 clinical trial of an ophthalmic solution containing SkQ1 for dry eye disease. As disclosed in the announcement of the Company dated 24 February 2021, positive outcome was achieved during second phase 3 clinical trial (VISTA-2). The clinical trial study repeated statistically significant positive results on key predefined secondary end-point (Central Corneal Fluorescein Staining). The Board is enthusiastic about the read-out of clearing of central staining of the cornea (defined as zero staining in central cornea), which reveals the potential of SkQ1 in addressing oxidative stress in dry eye diseases. Following the positive trial outcome of VISTA-2, Mitotech has planned a pivotal trial (VISTA-3), which will commence once Mitotech's management team has fully assessed there is no potential disruption to trial centres and patient recruitment during the ongoing COVID-19 pandemic. However, recent developments in Ukraine have led to governments and industries reacting to business relationships with Russia in a way that could potentially induce delays in Mitotech's VISTA clinical trial program.
HLX04-O approved for phase 3 clinical trial In 2020, the Group entered into a co-development and exclusive license agreement with Shanghai Henlius Biotech, Inc. to co-develop a pharmaceutical product that contains an anti-vascular endothelial growth factor ("anti-VEGF") as a drug substance, which is intended for the treatment of exudative (wet) age-related macular degeneration ("wet-AMD"). As at the date of 22 March 2022, the recombinant anti-VEGF humanised monoclonal antibody injection HLX04-O ("HLX04-O") for the treatment of wet-AMD has been approved to commence the phase 3 clinical trial in Australia, the United States, Singapore, Russia, Serbia and European Union countries such as Hungary, Spain, Latvia, the Czech Republic and Poland. Also, the first patient has been dosed in a phase 3 clinical study for HLX04-O for the treatment of wet-AMD in the PRC.
Ophthalmology business is expected to be further strengthened by the acquisition of Shilishun Iodized Lecithin Capsules
The successful acquisition of IP rights relating to R&D, production and MAH of Shilishun Iodized Lecithin Capsules will enable the Group to strengthen its ophthalmology business.
Robust Market Access Capability Over the years, the Group has been relentlessly investing in establishing and strengthening its market access capability. As at 31 December 2021, the Group maintains a network of 43 regional sales offices in the PRC and a total number of about 1,265 sales and marketing representatives, out of which 64% are full-time employees and 36% are on contract basis or from appointed agents.
More Extensive Healthcare Network for Product Prescription During the year under review, the Group's therapeutic products are being prescribed in more than 10,500 hospitals and medical providers, coupled with approximately 2,110 pharmaceutical stores, which are mainly located in the major cities, provinces and county cities in the PRC.
Further Investments to Strengthen Competitiveness and Customer Base For achieving a sustainable traction on growth for currently marketed products as well as for near-term to mid-term new products being commercialised, the Group initiated investments to improve its competitiveness and widen its customer base under the following plans:
-- Investing in clinical observation programs for affirming additional clinical indications of its commercialised products; -- Reaching out to market in lower-tier cities; -- Cultivating pharmaceutical stores, where possible, as complementary sales channel; and -- Building on-line platform for medical consultation and e-prescription for patients with chronic diseases under its healthtech initiative.
The Group has initiated its market access expansion to Southeast Asian countries by setting up a base and expanded its presence in Singapore since 2020.
Research and Development
The Group renewed its R&D's vision, emphasising the dedication to science and innovation, with a mission to develop therapeutics that would meet unmet clinical and/or commercial needs. The Group concurrently kick-started a 5-year (2021 to 2025) R&D's development plan to further strengthen its R&D capability and its position in Ophthalmology.
As at 31 December 2021, there are 15 R&D programs in the pre-clinical to clinical stage, out of which 3 ophthalmology programs are in clinical stage. The 3 ophthalmology programs listed below are targeted as mid-term growth driver.
1. EB11-18136P: SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021
2. EB11-15120P: Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC)
3. EB12-20145P: Bevacizumab intravitreal injection for wet-AMD, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC)
As at the date of this announcement, the Group has obtained a total of 44 patent certificates or authorisation letters: 35 invention patents, 4 utility model patents and 5 design patents.
The Group currently has diversified its R&D resources to multiple research sites in Zhuhai (PRC), Boston (United States), London (United Kingdom) and Singapore which supports not only our pursuit for new therapeutics but also our acquisition of global talent.
Looking ahead, the Group will continue to monitor the circumstances under the uncertainty of COVID-19 in 2022. Its strong team spirit and dynamic leadership have provided it with the capacity to navigate these turbulent times, and capture any opportunities in the ever changing world. The Group remains highly dynamic in delivering positive results in the coming year.
"COVID-19 remains a major concern in 2022 globally. We continue to monitor the situation and will take appropriate actions to overcome any unforeseen challenges. Barring the unforeseen circumstance, the Group remains focus on executing its plans and delivering progressive results. I would like to take this opportunity to express my sincere gratitude to all stakeholders, business associates and valued customers for the trust, support and cooperation accorded to us, and each and every member of the Group for their relentless efforts rendered in shaping the Group into being a progressive and promising pharmaceutical player.", said Mr. Patrick Ngiam.
About Essex Bio-Technology Limited (Stock Code: 1061.HK) Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic rb-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and Shilishun Iodized Lecithin Capsules etc.. The products of the Company are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 10,500 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comEssex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the annual results for the year ended 31 December 2021.
CAMBRIDGE, Mass., and TOKYO, Mar 22, 2022 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually.
Four key symposium presentations explored how lecanemab's clinical efficacy data, overall amyloid-related imaging abnormality (ARIA) rates, biomarker relationships to clinical outcomes, potential dosing regimens, and administration have the potential to benefit people living with early AD.
1. Science of the Amyloid Cascade and Distinct Mechanism of Action (MoA) of Lecanemab
- BioArctic's Professor Lars Lannfelt presented the science of the amyloid cascade and studies evaluating lecanemab's distinct binding profile to antibodies created from patented sequences of two other clinical antibodies, aducanumab and gantenerumab. The three antibodies have different binding profiles to Abeta species. All three antibodies bind to fibrils, but with different selectivity. Lecanemab was the strongest Abeta binder and prefers protofibrils. Lecanemab's binding profile is critical to enriching our understanding of the features in clinical outcomes and safety. BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD.
2. Key Trial Design Aspects and Clinical Outcomes of the Lecanemab Phase 2b (Study 201) Trial and Open-Label Extension (OLE) in Early AD
- Innovative Bayesian Adaptive Randomization Design and Dose Regimen-Finding Study with OLE - Study 201 (published by Eisai in Alz Res Therapy 13;21) was prospectively designed as a blinded 18-month study. To accelerate the development program, Eisai used a Bayesian adaptive design with a prespecified 12-month Bayesian primary endpoint in addition to the prespecified traditional analysis at the end of the 18-month treatment period. The OLE evaluated the long-term safety and tolerability of lecanemab and the effect of lecanemab on amyloid PET over 12 months of treatment, which looked at treatment naive patients (those on placebo during the core study) and those patients who had previously been treated with lecanemab, including earlier time points (3 and 6 months) than in the core phase (12 and 18 months). Eisai's study design provided the opportunity to explore the biomarker and clinical effects of stopping and restarting lecanemab across five years of disease trajectory.
- Rapid and Thorough Amyloid Clearance Correlates with Clinical Benefit - By using the Bayesian study design across a broad range of doses, researchers were able to efficiently and effectively identify the most effective dose, 10 mg/kg biweekly, to produce rapid and thorough amyloid clearance and potential clinical efficacy. Of the approximately 12 treatment-naive patients in the OLE (those who received placebo in the Core study), more than 40 percent were amyloid negative as early as 3 months and more than 80% were amyloid negative by 12 months as measured by PET image (visual read).(1) The OLE results are consistent with core phase results in which 65% were amyloid negative at 12 months(1) and 81% of participants were amyloid negative at 18 months as measured by PET image (visual read) in 161 subjects treated with 10 mg/kg biweekly dose. Robust amyloid reduction in those receiving lecanemab in the Core study was maintained while off-treatment over the Gap period. Despite the small number of participants in the OLE, findings help confirm the results from the Core study: lecanemab rapidly and thoroughly cleared amyloid plaque from the brain. Study 201 established 10 mg/kg biweekly as the most effective dose of lecanemab based on ADCOMS. Lecanemab could potentially be administered at 10mg/kg on the first day of treatment and continue at biweekly intervals without titration.
ARIA Incidence, Frequency, Severity and Modeling ARIA-E is an important adverse event of amyloid-lowering therapies that is critical to monitor and manage during treatment.
Study 201 Core ARIA-E Rates ARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: overall ApoE4 carriers 14.3% (7/49), ApoE4 carriers homozygous 50.0% (5/10), ApoE4 carriers heterozygous 5.1% (2/39) and ApoE4 non-carriers 8.0% (9/112). The overall ARIA-E rate in the Core study was 9.9% (16/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 0.8% (2/245) of placebo patients.
Study 201 OLE ARIA-E Rates Although ApoE carriers were underrepresented in the 10 mg/kg biweekly group in Study 201 Core, all participants entering Study 201 OLE (69.4% of whom were ApoE4 carriers) were treated with 10 mg/kg biweekly, and ARIA rates were consistent with those in the Core study. Forty-five participants who received placebo in the Core study joined the OLE. ARIA-E was observed in allele groups newly treated with 10 mg/kg biweekly in the OLE at the following rates: overall ApoE4 carriers 12.9% (4/31), ApE4 carriers homozygous 25.0% (1/4), ApoE4 carriers heterozygous 11.1% (3/27) and ApoE4 negative 0.0% (0/14). In the OLE study, overall ARIA-E rates were as follows: ApoE4 carriers 10.4% (13/125), ApoE4 carriers homozygous 14.3% (4/28), ApoE4 carriers heterozygous 9.3% (9/97) and ApoE4 non-carriers 1.8% (1/55).
Study 201 Core and OLE Pooled ARIA-E Rates In the Core and the OLE, ARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: ApoE4 carriers 13.8% (11/80), ApoE4 carriers homozygous 42.9% (6/14), ApoE4 carriers heterozygous 7.6% (5/66) and ApoE non-carriers 7.1% (9/126). The overall ARIA- E rate was 9.7% (20/206) of patients treated with lecanemab 10 mg/kg biweekly.
ARIA-E Rates Frequency and Severity In the Core study and OLE, the majority of ARIA-E events occurred within the first 3 months of treatment (75% [12/16]) and resolved within 4 months of onset. For the majority of patients, the radiographic severity was mild or moderate; severe radiographic severity was reported in 1.2% (2/161) of patients. The majority of ARIA-E was asymptomatic; with symptomatic ARIA-E reported in 1.9% (3/161) of patients. Symptoms reported in association with ARIA-E included headache, visual disturbance, confusion, aphasia. There has been a single case of ARIA-E associated with seizure in the Core study and OLE to date.
Exposure-Response Model Predicted and Observed ARIA-E vs. Cmax for APOE 4 The PK/PD exposure-ARIA-E model was developed from the Core study utilizing data from all doses and demonstrated that ARIA-E is driven primarily by Cmax. The ApoE4 genotype is a significant covariate in the model. The PK/PD model predicted ARIA-E by Cmax at the 10 mg/kg biweekly dose in the Core study by allele group as follows: ApoE4 carriers homozygous 22.5%, ApoE4 carriers heterozygous 6.8% and ApoE4 non-carriers 5.4%. In addition to the modeling predicting ARIA-E by Cmax in the Core study, it confirmed the observed ARIA-E in the OLE. Given the small data set for ApoE4 homozygous patients, this will be evaluated in Eisai's Phase 3 Clarity AD clinical trial.
ARIA-H Rates In the Core study, the incidence was higher in ApoE4 homozygous carriers than in ApoE4 heterozygous carriers and non-carriers. ARIA-H was observed in 6.2% (10/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 4.9% (12/245) of placebo patients. The rate of ARIA-H was higher in ApoE4 carriers (12.2% [6/49] vs placebo 5.2% [9/174]), than in ApoE 4 non- carriers (3.6% [4/112] vs placebo 4.2% [3/71]). All patients with microhemorrhage or superficial siderosis were asymptomatic. There has been one report of symptomatic cerebral macrohemorrhage. These data are hypothesis-generating and will be further evaluated in Clarity AD.
3. Phase 2b (Study 201) Lecanemab Early AD Study Biomarker Results, Correlations with Clinical Outcomes and Potential Less-Frequent Maintenance Dosing
- Abeta42/40 and P-Tau181 are plasma biomarkers that signal sequential changes in AD progression. Lecanemab has an effect on these plasma biomarkers as amyloid plaque reduction is related to soluble amyloid and P-Tau. Lecanemab has a dose- and time-dependent reduction of amyloid plaques with a correlated increase in plasma Abeta42/40 and a decrease in plasma P-Tau181. Changes in plasma Abeta42/40 and P-Tau18 also correlate with change from baseline Clinical Dementia Rating scale Sum of Boxes (CDR-SB). In the Core study, a correlation in change from baseline in amyloid PET SUVR and plasma Abeta42/40 ratio and plasma P-tau181 was observed at 18 months, indicating that plasma biomarkers could potentially help with measuring clinical changes.
- When lecanemab treatment was discontinued at the end of the Core study, changes in the plasma Abeta42/40 (47%), P-Tau18 (24%), and amyloid PET SUVR (21%), gradually began to reverse, suggesting stopping therapy prematurely may potentially allow re-accumulation of pathology. Less frequent maintenance treatment to prevent re-accumulation may be possible based on data and modeling. Eisai will further explore maintenance dosing in the subcutaneous substudy of the Study 201 OLE, which will evaluate alternative dosing every 4 weeks or every 12 weeks.
- Increasing strong evidence highlights the role of amyloid plaques in triggering tau dysregulation and researchers optimize tau therapeutics by removing a key driver of tau dyshomeostasis (amyloid). For this reason, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, selected lecanemab as the backbone anti-amyloid therapy for anti-tau combination for the ongoing component of the Tau NexGen clinical study, which continues enrollment efforts.
4. Update on Lecanemab Clinical Development, Including New Subcutaneous Formulation Eisai's Dr. Michael Irizarry Senior VP of Clinical Research and Deputy Chief Clinical Officer presented updates on key lecanemab clinical trials.
- Clarity AD Phase 3: The innovative Bayesian design of lecanemab's robust dose-ranging Phase 2b study allowed Eisai to design the Phase 3 confirmatory Clarity AD clinical trial to verify lecanemab's clinical efficacy and safety in early AD. Enrollment is complete with 1,795 participants globally. Additionally, Eisai's recruitment strategy for the Clarity AD clinical trial ensured greater inclusion of ethnic and racial populations in the U.S., resulting in approximately 25% of the total U.S. enrollment including Hispanic (22.5%) and African American (4.5%) persons living with early AD, which mirrors the U.S. Medicare population. The readout will occur in Fall 2022.
- AHEAD3-45 Phase 3 Study in Preclinical AD: As of March 2022, there were over 2,900 people screened, resulting in 287 participants enrolled.
- Clarity AD Subcutaneous Substudy: Eisai is developing a subcutaneous formulation of lecanemab with the potential to be administered at home by the patient or caregiver via an auto-injector with a more rapid administration than the IV formulation (<15 second SC injection versus ~1h infusion). PK/PD modeling of Study 201 suggests that the average lecanemab concentration (Cave) predicts amyloid clearance while the maximal lecanemab concentration (Cmax) predicts ARIA-E rate. Since subcutaneous administration results in a blunted Cmax, the SC dose with comparable Cave to 10 mg/kg IV is hypothesized to have similar amyloid reduction with potentially reduced incidence of ARIA-E relative to IV but less than half the ARIA- E rate as IV. Eisai is evaluating the SC formulation in the Clarity AD OLE.
"The invited lecanemab presentations at AD/PD provide new and exciting insights into how the mechanism of action of late-stage anti-amyloid antibodies differ and how that may help simplify the patient journey by offering a less frequent dosing regimen while providing long-term benefit," said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai. "Eisai aims to bring these potential innovations to people living with early AD and healthcare providers as quickly as possible as we work to fulfill our human health care mission."
Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway. Eisai expects to complete this rolling submission in the first quarter of our fiscal year 2022, which begins April 1, 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.
(1) Swanson C.et all, November, 9-12, 2021, Clinical Trials On Alzheimer's Disease Annual Meeting, Lecanemab: An Assessment of the Clinical Effects, the Correlation of Plasma Abeta 42/40 Ratio With Changes in Brain Amyloid PET SUVr, and Safety from the Core and Open Label Extension of the Phase 2 Proof-of- Concept Study, BAN2401-G000-201, in Subjects With Early Alzheimer's Disease.
MEDIA CONTACT: Eisai Co., Ltd. Public Relations Department +81-(0)3-3817-5120
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually.
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