Assembly Biosciences (ASMB) Commences ABI-H0731 Phase 1 as HBV Treatment

November 9, 2016 7:10 AM EST
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Assembly Biosciences, Inc. (Nasdaq: ASMB) 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.

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