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Assembly Biosciences begins Phase 1 clinical trial of ABI-H0731 for treating chronic hepatitis B virus infection.

M2 PHARMA-November 10, 2016-Assembly Biosciences begins Phase 1 clinical trial of ABI-H0731 for treating chronic hepatitis B virus infection


Biotechnology company Assembly Biosciences (NasdaqCM:ASMB) revealed on Wednesday the start of a Phase 1a/1b clinical trial of ABI-H0731 for the treatment of chronic HBV.

The Phase 1a study will assess the safety, tolerability and pharmacokinetics of ABI-H0731, its initial Core protein Allosteric Modifier (CpAM), in healthy volunteers.

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

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.

According to the company, CpAMs are direct-acting antivirals that allosterically modulate core protein. In preclinical HBV infection assays, CpAMs has shown to suppress both viral replication and the cccDNA formation associated with viral persistence.

HBV afflicts an estimated 240m people worldwide and is a leading cause of chronic liver disease and liver transplants. 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.

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Publication:M2 Pharma
Date:Nov 10, 2016
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