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Logility VPs Dario Fischli and Jonathan Jackman recently hosted a webcast on overcoming ever-increasing business disruptions today while building a sustainable supply chain for tomorrow. It turns out these initiatives are two sides of the same coin.  Indeed, today’s supply chain disruptions are occurring more frequently, narrowing the window of opportunity for business leaders to […]

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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.

Contacts:

MEDIA CONTACT:
Eisai Co., Ltd.
Public Relations Department
+81-(0)3-3817-5120

Eisai Inc. (U.S.) Libby Holman
+ 1-201-753-1945
Libby_Holman@eisai.com

INVESTOR CONTACT:
Eisai Co., Ltd.
Investor Relations Department
+81-(0)70-8688-9685

MEDIA CONTACT:
Biogen Inc. Ashleigh Koss
+ 1-908-205-2572
public.affairs@biogen.com

INVESTOR CONTACT:
Biogen Inc. Mike Hencke
+ 1-781-464-2442
IR@biogen.com

For more information, visit https://www.eisai.com/news/2022/pdf/enews202221pdf.pdf.


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.

Today, the Securities & Exchange Commission voted 3 to 1 in favor of adopting a long-awaited set of proposed revisions to SEC regulations concerning the disclosure of climate risks and related financial impacts, as well as data on greenhouse gas emissions in certain SEC filings. The recommendation to adopt the new set of rules was not unanimous, with Commissioner Hester Peirce voting against the measure, arguing that the new set of rules is at best unnecessary,… More

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RFOX, a fast-growing metaverse company building the future of the Internet, has announced it has established a new regional office in Dubai. The company is currently domiciled in Southeast Asia and has carved out a reputation as one of the hottest blockchain companies. 

What makes RFOX unique is the RFOX VALT metaverse, a virtual world that the company is building in virtual reality (VR), and its integration with the multiple other businesses the company has already built to create a vibrant ecosystem. The RFOX VALT is focused on shopping, retail, and entertainment experiences, offering users the ability to have new and immersive experiences with their favourite brands and celebrities in VR.

RFOX established a roadmap to build a metaverse two years ago. The Company's plans accelerated once Facebook announced it was pivoting to become a metaverse-focused company called Meta. Fortunately for RFOX, its plans to build a metaverse were fairly advanced. RFOX is one of the few companies that have specifically targeted both retail and entertainment sectors for its metaverse focus. Analysts Emergen Research have identified both sectors to dominate the metaverse market, estimated at USD 1.6 trillion by 2030.

Co-founder and CEO, Ben Fairbank praised the Dubai government, especially its ruler Sheikh Mohammed Bin Rashid Al Maktoum, for the foresight and vision for virtual assets and the crypto industry. “We looked at multiple jurisdictions, and after careful review, we decided that Dubai was making great progress in giving users confidence in virtual assets. Dubai's adoption of the Virtual Asset Regulation Law, the first law governing virtual assets, and the establishment of a regulator to oversee the sector will help facilitate the mainstream adoption of virtual assets. We also looked at the ecosystem in Dubai and found we were in good company with organisations such as Binance and Meta also taking up strategic positions in Dubai. We are optimistic about our future in the region”, said Ben Fairbank, CEO of RFOX.  

About RFOX

RFOX is a metaverse company with a mission to be the global leader in immersive metaverse experiences focused on retail, media, gaming, and rewards, through the RFOX VALT metaverse. Since 2018, the company has built the RFOX ecosystem of products and solutions that include online games (RFOX Games), white-label NFT platform (RFOX NFTs), DeFi products (RFOX Finance), digital media platforms (RFOX Media and RFOX TV), and more. Its main token is RFOX, the digital asset that fuels the RFOX metaverse ecosystem and its immersive technology.

Media Contact

Ira Go

Email: ira@rfox.com

Contact: +639155500764

Subscriptions are an integral part of modern life. Digital subscriptions are increasingly common as more people get content from various subscription channels, unlike the past few decades where cable TV was the default source. Accordingly, the need to support crypto payment for Netflix and other subscription services is on the rise, even timely.

Revuto is a subscription management platform on Cardano that aims to add efficiency and control to the payment of subscriptions. They are now joining hands with Genius Yield, an equally innovative order-book DEX launching on Cardano to fast-track the adoption of DeFi services. While both protocols would support each other's ecosystem, a standout benefit would be paying for Netflix, Apple TV, Amazon, DSTV, and other subscription services using Genius Yield's GENS and other Cardano tokens. It is a vital support allowing users to take control of their spending, save money, while also earning cashback in Revuto's REVU tokens. Meanwhile, it will be possible for users to earn GENS by staking REVU via the ISPO in the Revuto Staking Center.

Streaming services can be annoying with their subscription models for all their quality content. You have probably heard a friend or relative furious over the billing policies of one of their subscriptions. The problems range from difficulties in cancellation, automatic renewal, and other communication-related issues. 

A Blockchain-Based Subscription Service

The fundamental issue with most subscriptions is that they rely on credit cards or bank payments. Once you sign up and agree to terms that most people never read, the subscription service can automatically deduct from your bank account. 

Revuto introduces the concept of a virtual debit card to grant users more control over subscription payments, allowing users to pay with Cardano and its tokens. The idea is to have a decentralized application that users can utilize to manage their subscriptions. This virtual debit card is operationalized as a decentralized application (dApp) that runs on the Cardano blockchain. 

Here is a summary of how the subscription management app will work:

• Download the Revuto app and set up an account, a straightforward process;

• Add subscriptions you intend to manage. They could range from music streaming services like Netflix, software packages, and more. 

• Once the subscriptions are linked, you can begin paying using GENS and other supported tokens.

The real prize is your ability to block, snooze, and generally control payments to your subscription service. This versatility allows the account holder to prevent unwanted subscription charges that make subscriptions more expensive than what you signed up for. Besides, you don't have to cancel the subscription when you want to snooze payments for a while before resuming.

The Cardano Blockchain Provides Base Support 

Revuto achieves its high performance because it launches from a robust layer, built from the ground up with the intention of being inherently scalable. The Cardano crypto blockchain is the handiwork of Ethereum co-founder Charles Hoskinson and a team of developers who sought to create a high-functionality and research-based network. 

Accordingly, Cardano is an excellent host for decentralized systems and applications. The rise of Decentralized Finance (DeFi) bodes well for this bespoke blockchain and its native coin, ADA. The protocol has significantly higher throughput than Ethereum, implementing a unique architecture with different settlement and computation layers. Accordingly, smart contract execution does not clash with transactions, as is the case for Ethereum.

Using Cardano blockchain, this utility has allowed an integrated decentralized hub like Genius Yield, SundaeSwap, and others to thrive. Its efficiency and increasing stature in the DeFi sector fit well with services that offer a secure and fast settlement. 

More Than Just Subscriptions Management 

Meanwhile, with Revuto in the picture, users can make payments efficiently and leverage recurring payments with REVU and get extra services for money management. Revuto received three million early sign-ups for dApp, with hundreds of thousands of users worldwide. These numbers bode well for an upcoming Fintech startup earning Revuto accolades like the award for the fastest-growing consumer product at the recent World Blockchain Summit in Dubai.

The ability to pay for your subscriptions in Cardano tokens is revolutionary. Bitcoin has struggled to gain traction as a medium of exchange for all its popularity. This utility application provides a real-world use for cryptocurrency. 

Revuto is looking to make its app a wholesome product. Soon, users will be able to exchange fiat and crypto in real-time and other decentralized finance services like lending and borrowing. Overall, the subscriptions management platform will provide a mobile-friendly and excellent decentralized finance management tool. The decision to launch on the Cardano blockchain is a testament to this vision. Revuto has a native Cardano mobile and non-custodial wallets with plans to add their custodial wallet to augment user experience.

Forecasting Growth in The Subscriptions Sector 

The world is trending online by the year. This trend is likely to manifest in the subscriptions and billing management sector, with the global market estimated to grow from about $3.9 billion today to $7.4 billion in 2027. The accelerated growth of digital streaming services is the biggest growth driver. it is the golden age for streaming with more potential in developing markets

There is excellent potential for a subscriptions management tool with such a market size. There will be tens, even hundreds of millions more people joining this demographic in the next few years. Accordingly, Revuto is entering the scene strategically for all stakeholders.

Looking Forward

Cryptocurrency and the blockchain launched on the fundamental premise that consumers need more control of their finances. This idea is relevant in countless fields. Subscriptions fall in this category because some services are downright abusive in their billing policies. Genius Yield and Revuto take the tenets of decentralization and user empowerment in these industries and seek to transform how consumers relate to subscription services. There is a great need for such services. By forming a fitting coalition, Genius Yield and Revuto will likely reap from the appreciation users will have for such convenience.

Media Contact

Company Name :- Genius Yield

Email Id :- hello@geniusyield.co

Company Website :- https://www.geniusyield.co/

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