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Arrowhead Interim Clinical Data Demonstrate ARO-AAT Treatment Improved Multiple Biomarkers of Alpha-1 Liver Disease

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Home > Press > Arrowhead Interim Clinical Data Demonstrate ARO-AAT Treatment Improved Multiple Biomarkers of Alpha-1 Liver Disease

Abstract:
– Serum Z-AAT reductions of 86-93%

– All patients demonstrated greater than 80% reduction in liver Z-AAT monomer

– 3 of 4 patients had a decrease in liver globule involvement

– 3 of 4 patients demonstrated reductions in Z-AAT polymer with a range of 68-97%

– All patients showed ALT reductions ranging from 36-66%

Arrowhead Interim Clinical Data Demonstrate ARO-AAT Treatment Improved Multiple Biomarkers of Alpha-1 Liver Disease


Pasadena. CA | Posted on November 13th, 2020

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced positive interim clinical data from AROAAT2002, an open-label Phase 2 clinical study of ARO-AAT, the company’s second-generation investigational RNA interference (RNAi) therapeutic being developed as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency (AATD). The data demonstrate that three doses of ARO-AAT over 24-weeks resulted in consistent reductions of the disease-causing mutant Z protein (Z-AAT) and improvements in clinically relevant biomarkers of liver disease. The results were presented in a late-breaking poster at The Liver Meeting Digital Experience, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD).

A copy of the poster may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

Javier San Martin, M.D., chief medical officer at Arrowhead, said: “These data presented at AASLD strongly suggest that ARO-AAT is doing what it’s designed to do, which is reduce the production of the misfolded mutant Z-AAT protein. Moreover, these compelling results indicate that the liver may have the ability to clear out accumulated Z-AAT and begin to heal itself faster than anticipated. Importantly, we saw reductions in serum Z-AAT and liver Z-AAT which led to improvements in multiple markers, such as liver globules, ALT/GGT and Pro-C3. These are all positive indications of a strong pharmacodynamic response and improvement in liver health, following just three doses of ARO-AAT. We anticipate data from additional patient cohorts will be available in the coming months, which will be included in our planned discussions with the U.S. Food and Drug Administration and other regulatory agencies, aimed at exploring areas where the ARO-AAT program could potentially be streamlined and accelerated.”

In the AROAAT2002 study, four patients with homozygous PiZZ alpha-1 antitrypsin deficiency and evidence of fibrosis at screening, each received three doses of ARO-AAT on week 0, 4, and 16. Liver biopsies were performed at screening and at week 24. Assessments included safety (including pulmonary function tests), changes in serum Z-AAT, liver Z-AAT, ALT, GGT, Pro-C3, liver elastography (FibroScan®), and liver globule assessment. Additional histologic adjudication is ongoing.

Key data presented include the following:

Pharmacodynamic Response at 24 weeks

Serum Z-AAT reductions were 86-93%
Total intra-hepatic Z-AAT reductions were 72-95%
All patients demonstrated greater than 80% reduction in liver Z-AAT monomer (soluble)
3 of 4 patients demonstrated reductions in Z-AAT polymer (insoluble) with a range of 68-97%
3 of 4 patients had a decrease in liver globule involvement and 1 subject remained unchanged
All patients showed reductions in ALT (range 36-66%) and in GGT (range 43-58%)
3 of 4 patients demonstrated a substantial reduction of greater than 20% in FibroScan® values
3 of 4 patients showed greater than 30% reduction in serum Pro-C3, a marker of fibrogenesis
Safety

Overall, ARO-AAT 200 mg as a subcutaneous injection was well tolerated in PiZZ AATD subjects
One treatment emergent SAE of Epstein bar virus related myocarditis was reported
No treatment emergent AEs related to change in pulmonary status or pulmonary function were reported
No clinically meaningful changes in ppFEV1 from baseline to Week 24 were observed
In October 2020, Arrowhead and Takeda Pharmaceutical Company Limited announced a collaboration and licensing agreement to develop ARO-AAT. Under the terms of the agreement, Arrowhead and Takeda will co-develop ARO-AAT which, if approved, will be co-commercialized in the U.S. under a 50/50 profit-sharing structure. Outside the U.S., Takeda will lead the global commercialization strategy and receive an exclusive license to commercialize ARO-AAT with Arrowhead eligible to receive tiered royalties of 20-25% on net sales. Arrowhead will receive an upfront payment of $300 million and is eligible to receive potential development, regulatory and commercial milestones up to $740 million. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the U.S.

AROAAT2002 (NCT03946449) is a pilot open-label, multi-dose, Phase 2 study to assess the response to ARO-AAT in approximately 16 patients with AATD associated liver disease and baseline liver fibrosis who will be enrolled in three cohorts. All eligible participants will require a pre-dose biopsy and an end of study biopsy. Treated participants will also be offered the opportunity to continue treatment in an open-label extension (OLE). Including the OLE, interim assessments will be made after 6 months and 18 months (cohorts 1, 1b), and 12 months and 24 months (cohort 2) of treatment with ARO-AAT. Arrowhead is also evaluating ARO-AAT in the ongoing SEQUOIA Phase 2/3 trial, which began in August 2019.

####

About Arrowhead Pharmaceuticals, Inc.
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

For more information, please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts .

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the safety and efficacy of our product candidates, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

For more information, please click here

Contacts:
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400

Investors:
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578
www.lifesciadvisors.com

Media:
LifeSci Communications, LLC
Josephine Belluardo, Ph.D.
646-751-4361
www.lifescicommunications.com

Copyright © Arrowhead Pharmaceuticals, Inc.

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

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STid SPECTRE nano Reader Accelerates Car Park Access Control with…

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STid launches Spectre nano reader

Our SPECTRE nano reader offers a faster entry/exit process and simple, hands-free use with top end-to-end security for hospitals, government agencies, universities and more.

STid, creator of the world’s most awarded access control reader, announced today it has set a new standard in car park access control and simplified visitor management with its new SPECTRE nano reader. The multi-technology reader quickly recognizes employees, visitors, vendors, and their vehicles – simultaneously – for smooth, hands-free access control without compromising security.

Easy to use, “all terrain” reader

The next generation, hands-free reader increases speed of entry for anyone – or anything – on two feet, two wheels, four wheels or a whole fleet. It reads windshield tags, key fobs, cards, smartphones, or wearables using UHF and Bluetooth® to leverage end-user preferences for easier adoption. It is also part of the STid Mobile ID® ecosystem, which turns smartphones into virtual cards for both vehicle and pedestrian access control.

Compatible with all access control systems worldwide, STid designed SPECTRE nano for easy integration regardless of managers’ tech expertise. The outside packaging is as rugged and durable as the technology to ensure the reader can stand up to harsh environments – everything from shock, heavy rain, and dust, to salt, frost, and fire. SPECTRE nano offers customized branding options to fit in at a bus station, corporate office, or private community, and is able for use in high-security industries. A cost-effective solution, the new reader can be installed and (almost) forgotten, with no maintenance or batteries required.

“We’ve all experienced the long wait time to get in and out of parking garages trying to pay tolls or scan access badges, tolls or gates,” said Frederick Trujillo, U.S. operations manager, STid. “Our new SPECTRE nano reader solution offers a faster entry/exit process and simple, hands-free use with top end-to-end security for hospitals, government agencies, universities and more. Parking areas are especially vulnerable to theft, damage, vandalism and even acts of terrorism making improved access control critical.”

Designed for global customers, SPECTRE nano uses OSDP™ and SSCP® protocols and has EAL5+-certified storage. Data authenticity and confidentiality are ensured using encryption methods recommended by worldwide organizations, e.g., ANSSI- & FIPs-compliant. Encrypted, signed credentials provide anti-cloning and anti-replay protection and managers can quickly erase security keys, when necessary.

SPECTRE nano will be available in October to help speed car park access control. For more information, please visit our SPECTRE Nano page.

About STid

STid’s mission is to protect people, their property and data through secure access and identity. For more than 25 years, STid has created and marketed identification solutions for high security physical and logical access control, as well as Automatic Vehicle Identification. The Company aims for businesses, residential, governments and industry to simplify and protect their digital identity management by developing non-proprietary intelligent identification solutions that use state-of-the-art RFID, NFC, Bluetooth® and Internet things of Things (IoT) technology. A recognized pioneer in its field, STid was at the forefront by being the first manufacturer to obtain First Level Security Certification (CSPN) from the French government agency ANSSI for its access control solutions. With eleven awards, STid offers the product line – the Architect° series of readers – most awarded in the world by security experts. STid recently launched the new SPECTRE nano UHF and Bluetooth® reader for easy vehicle and driver access control.

For more information contact: marketing@stid.com

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AerHome Makes People Smarter about the Air in their Homes

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AerNos AerHome

Many factors, including COVID-19, wildfires and other climate-related extreme weather, have raised awareness about indoor air and the health implications. We are leveraging our experience to help make people smarter about the air in their homes and keep their families healthy

Air pollution is bad for our health and can be especially problematic for infants and young children contributing to asthma, autism, obesity, diabetes, ADHD and other mental health issues. In fact, the World Health Organization (WHO) describes indoor air pollution as the greatest environmental health risk to people.

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AerNos is partnering with the Sean Parker Allergy and Asthma Research Center at Stanford University to help them better understand the impact of breathing polluted air from wild fires on children in school and at home. The Center will provide AerHome devices to schools and families and use the data to develop recommendations to improve air quality and prevent disease to improve learning, decrease absenteeism, and ultimately decrease disparities in health outcomes.

AerHome is launching today on Indiegogo with the opportunity to gift units for Stanford’s research in addition to purchasing AerHome units for the home.

“While, AerNos has spent the past five years developing application-specific nano gas sensor modules for the B-B market, we are using our expertise to help people improve the air quality in their homes,” explained Sundip Doshi, founder and CEO. “Many factors, including COVID-19, wildfires and other climate-related extreme weather, have raised awareness about indoor air and the health implications. We are leveraging our experience to help make people smarter about the air in their homes and keep their families healthy.”

# # #

About AerNos

AerNos, Inc. develops application-specific nano gas sensors based on its breakthrough and proprietary AerN2S™ Technology to detect harmful gases in the environment. AerNos nano gas sensors are designed to be easily integrated into consumer and commercial product lines, such as standalone monitoring devices, non-stationary devices (e.g., drones, industrial robots, construction equipment), modes of transportation, wearables, smartphones, and IoT. AerHome™, AerBand™, AerCity™, AerHome™, and AerNos™ are trademarks of AerNos, Inc. For more information, please visit http://www.AerNos.com. You may also contact us at media@AerNos.com.

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Powercast’s RF Wireless Power Technology Awarded for Global…

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Powercast aims to save millions of one-time-use batteries from entering landfills yearly

Powercast’s RF Wireless Power Technology Wins Global Sustainability Award for Reducing Battery Use, E-Waste

We’re partnering with many manufacturers to create wirelessly rechargeable devices that keep batteries out of landfills. Charles Goetz, CEO of Powercast.

The Business Intelligence Group today awarded Powercast with its Sustainability Initiative of the Year in the 2021 Sustainability Awards program. These awards honor those people, teams and organizations who have made sustainability an integral part of their business practice or overall mission.

Powercast aims to make one-time-use batteries obsolete by working with electronic manufacturers to recharge batteries or replace them altogether with its over-the-air RF (radio frequency) wireless power technology. Many of today’s small electronic devices can be designed so they’re environmentally friendly, either with rechargeable batteries that can accept an RF wireless charge, or with no batteries that can be directly powered by RF power. A Powerharvester chip is embedded in devices to receive RF energy sent over the air from either a dedicated Powercast transmitter, or from industry-standard RFID readers. The Powerharvester then converts the RF to direct current (DC) to top off the battery or power the device.

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“We’re already partnering with many manufacturers to create wirelessly rechargeable devices that keep batteries out of landfills,” said Charles Goetz, CEO of Powercast. “But, we strive for the day where all devices will charge in the background when consumers enter their home, office or car, where they’ll never have to throw batteries away.”

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About Powercast

Powercast is the established leader in RF wireless power. Since its founding in 2003, Powercast has led the industry in RF wireless power innovations and applications that meet FCC and other global standards. Powercast’s wireless power technologies eliminate or reduce the need for wires and batteries, working at distances up to 80 feet. With millions of units shipped, Powercast is led by a team with deep expertise in design, engineering, and prototyping, and with extensive commercial success in both industrial and consumer applications. With more than 100 customers and partner companies around the world, Powercast leads the RF wireless power market with 63 early and fundamental patents worldwide and 34 patents pending. For more information, visit http://www.powercastco.com.

About Business Intelligence Group

The Business Intelligence Group was founded with the mission of recognizing true talent and superior performance in the business world. Unlike other industry award programs, business executives—those with experience and knowledge—judge the programs. The organization’s proprietary and unique scoring system selectively measures performance across multiple business domains and then rewards those companies whose achievements stand above those of their peers.

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Source: https://www.prweb.com/releases/powercasts_rf_wireless_power_technology_awarded_for_global_sustainability_for_reducing_battery_use_and_e_waste/prweb18175001.htm

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High Performance, Closed-Loop Piezo Controller with Integrated Piezo…

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Learn about PI’s new high-performance, compact digital closed-loop piezo controller that’s cost effective too!

Learn about PI’s new high-performance, compact digital closed-loop piezo controller that’s cost effective too!

Based on 5 decades of piezo driver and motion controller expertise, PI’s digital piezo controller family grows again with the next generation E-709 closed-loop piezo controller and integrated driver, well suited for applications that require high performance motion with nanometer precision such as found in semiconductor surface metrology, autofocus systems, medical apparatus, laser-beam steering, 3D imaging, and multiphoton and confocal microscopy.

Digital Controller with Fast Focus and Freeze, Automated Scans, Software Support

The new E-709 compact digital piezo servo controller / amplifier and driver was designed providing 20kHz sampling rate, twice the power of its predecessor along with multiple times is positioning resolution. When used in image processing, scanning and microscopy applications, its advanced features such as high-performance linearization, high speed tracking, and PI’s unique F3 capability (Fast Focus & Freeze) come in handy. When used with a fast objective focusing motor such as the P-725, the autofocus drive can be bumplessly switched from an external (focus) sensor to the integrated position sensor inside the focusing stage. This feature allows for calibrated, precise, and highly stable motions on a nanometer scale, with respect to the focal plane.

Software – Digital vs. Analog Closed-Loop Piezo Controllers

The new E-709 compact digital piezo controller is supported by a comprehensive software package including drivers for LabVIEW, dynamic libraries for Windows and Linux, MATLAB, MetaMorph, µManager, etc. Despite all servo operations inside the controller are of digital nature, an additional analog control interface with high resolution A/D converters is included for ease of use with existing analog signals. Digital interfaces include USB, SPI, RS-232. Supported functions include Wave generator, data recorder, auto zero, and trigger I/O. The following article explains the difference between digital piezo servo controllers and analog piezo controllers.

How to Find the Right Piezo Controller?

Several application parameters should be considered when selecting the right closed-loop piezo controller for a specific nanopositioning or high-speed precision motion task. Examples are

  • Maximum required stroke / amplitude
  • Signal type (sinusoidal, triangular, trapezoidal, steps, …)
  • Frequency / duty cycle of the drive signal
  • Rise / fall time of steps
  • Operation time (Continuous 24/7, a few minutes or seconds at a time, …)

To learn more on this subject, a selection guide on Piezo Controllers and Mechanisms is available.

Safety Monitoring, Temperature Management

Short-circuit proof, the E-709 provides safety and monitoring functionality with continuous input/output measurements as well as internal temperature. The driver is adaptable to a wide variety of operating conditions and temperature stable within 10 minutes of powering on.

Datasheet» E-709 Compact, High Performance Closed-Loop Piezo Controller with Integrated Voltage Amplifier

Working with You

PI’s in-house engineered solutions have enabled customers around the world to increase their productivity and technological advantage for 5 decades. With a large basis of proven motion technologies and methodologies, PI is in the position to quickly modify existing designs or provide a fully customized OEM solution to fit the exact requirements of your application from sensors and piezo transducers to microscope nano-focus units, fast photonics alignment systems to multi-axis automation sub-systems.

USA / Canada

http://www.pi-usa.us | info@pi-usa.us | (508) 832-3456

About PI

PI is a privately held company that designs and manufactures world-class precision motion and automation systems including air bearings, hexapods and piezo drives at locations in North America, Europe, and Asia. The company was founded 5 decades ago and today employs more than 1300 people worldwide. PI’s customers are leaders in high-tech industries and research institutes in fields such as photonics, life-sciences, semiconductors, and aerospace.

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