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Phase 1 clinical program of ABI-H0731 for hepatitis B initiated

November 09, 2016

Assembly Biosciences initiates Phase 1 clinical program of ABI-H0731 for treatment of chronic hepatitis B virus infection

First of Assembly’s novel series of HBV core protein allosteric modulators enters clinical development

INDIANAPOLIS, Nov. 09, 2016 — Assembly Biosciences, Inc. (NASDAQ:ASMB), a clinical-stage biotechnology company advancing a new class of oral therapeutics for the treatment of hepatitis B virus (HBV) infection and novel oral biotherapeutics for disorders associated with the microbiome, today announced initiation of a Phase 1a/1b clinical trial of ABI-H0731, its initial Core protein Allosteric Modifier (CpAM) for the treatment of chronic HBV.

The Phase 1a study will assess the safety, tolerability and pharmacokinetics of ABI-H0731 in healthy volunteers. Subsequently, a Phase 1b study will assess the safety, pharmacokinetics and preliminary antiviral efficacy in patients with chronic HBV infection. The company expects to report trial results in the second half of 2017.

“This first clinical study is an important milestone for Assembly,” said Uri Lopatin, MD, chief medical officer and vice president of research and development of Assembly Biosciences. “Assembly is committed to developing new oral therapies with curative potential for chronic HBV, a serious disease with low cure rates that afflicts millions of people worldwide. ABI-H0731 is the first clinical candidate to emerge from our CpAM platform, which we believe will prove to be a productive source of compounds designed to attack HBV at multiple points in the viral lifecycle. We expect to initiate additional studies of ABI-H0731 in 2017, as we continue to advance other CpAM candidates towards clinical trials.”

Assembly aims to improve on the current low cure rates for chronic HBV by targeting the HBV core protein, an essential viral protein involved in multiple critical functions throughout the HBV lifecycle. Assembly’s CpAMs are direct-acting antivirals that allosterically modulate core protein. In preclinical HBV infection assays, Assembly has shown that CpAMs can suppress both viral replication and the cccDNA formation associated with viral persistence.

About Chronic Hepatitis B Virus

HBV afflicts an estimated 240 million people worldwide and is a leading cause of chronic liver disease and liver transplants. An estimated 500,000 to one million people die every year from HBV-related causes. The U.S. Centers for Disease Control reports that almost two million Americans are chronically infected with HBV. There is a great unmet need for more effective therapies for chronic HBV – the current standard of care effectively suppresses but does not cure the condition in the vast majority of patients.

About Assembly Biosciences

Assembly Biosciences, Inc. is a public biotechnology company developing two innovative platform programs: an HBV program advancing a new class of oral therapeutics for the treatment of hepatitis B virus (HBV) infection and a microbiome program developing novel oral biotherapeutics designed to address diseases associated with the microbiome. Assembly‘s HBV program is advancing multiple drug candidates with the aim of increasing cure rates in patients with chronic HBV. The company’s microbiome program consists of a fully integrated platform that includes a robust strain identification and selection process, methods for strain isolation and growth under current Good Manufacturing Practices and a patent-pending delivery system, GEMICEL®, which allows for targeted oral delivery of live biologic and conventional therapies to the lower gastrointestinal tract. The lead program from this platform is in development for the treatment of C. difficile infections. Assembly is also developing additional microbiome product candidates. For more information, visit assemblybio.com.

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