Assembly Biosciences Announces FDA Fast Track Designation Granted to ABI-H2158 for the Treatment of Chronic Hepatitis B Virus Infection

Rhea-AI Summary

Assembly Biosciences, Inc. (Nasdaq: ASMB) announced that the FDA has granted Fast Track designation to ABI-H2158 for treating chronic HBV infection, potentially expediting its development and approval. This second-generation core inhibitor is currently in a global Phase 2 trial, complementing the company's first-generation drug ABI-H0731, which also holds Fast Track designation. The company emphasized the significance of providing innovative treatments for the over 250 million people affected by HBV globally.

Positive

• FDA Fast Track designation granted to ABI-H2158, potentially accelerating development and approval.
• Strong clinical evidence of ABI-H0731 showing superior antiviral activity compared to traditional treatment.

Negative

• None.

SOUTH SAN FRANCISCO, Calif., July 09, 2020 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABI-H2158 (2158) for the treatment of patients with chronic HBV infection. 2158 is Assembly’s second-generation core inhibitor, which is being evaluated in an ongoing global Phase 2 trial.

The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate's development, review and potential approval. The Company previously received Fast Track designation for its first-generation core inhibitor ABI-H0731, currently in Phase 2 development.

“We are pleased to have received Fast Track designation for our second-generation core inhibitor 2158 for the treatment of chronic hepatitis B virus infection, a condition that affects over 250 million people worldwide with more than one million infected individuals in the United States,” said Luisa Stamm, MD, PhD, Chief Medical Officer at Assembly Biosciences. “This designation holds several important advantages to expedite the development and regulatory review of 2158 and underscores the importance of providing novel treatments to patients.”

About Assembly Biosciences’ HBV Core Inhibitor Portfolio
Assembly’s HBV portfolio includes three clinical-stage small molecules, all of which are HBV core inhibitors that target multiple steps of the HBV life cycle. In Phase 2 clinical trials, first-generation core inhibitor ABI-H0731 administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy has been well-tolerated, has shown statistically superior antiviral activity in HBV DNA suppression compared to NrtI therapy alone, and has demonstrated significant declines in pgRNA that may indicate decreased cccDNA levels. Assembly’s HBV portfolio also includes two potent second-generation candidates, ABI-H2158 in a Phase 2 clinical trial and ABI-H3733 in Phase 1 development.

About Assembly Biosciences
Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly’s fully integrated platform, including a robust process for strain identification and selection, GMP manufacturing expertise and targeted delivery to the lower gastrointestinal tract with the GEMICEL^® technology. For more information, visit assemblybio.com.

Contacts
Assembly Biosciences, Inc.
Lauren Glaser
Senior Vice President, Investor Relations and Corporate Affairs
(415) 521-3828
lglaser@assemblybio.com

FAQ

What is the significance of the FDA Fast Track designation for ASMB?

The FDA Fast Track designation allows for expedited development and review of ABI-H2158, enhancing its chances for quicker approval.

What is ABI-H2158 and its current status?

ABI-H2158 is Assembly's second-generation core inhibitor, currently in a global Phase 2 clinical trial for chronic HBV infection.

How many people are affected by chronic HBV globally?

Chronic HBV infection affects over 250 million people worldwide.

What prior designations has Assembly Biosciences received for its HBV treatments?

Assembly has previously received Fast Track designation for its first-generation core inhibitor, ABI-H0731.