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Assembly Biosciences Announces ABI-H0731 Phase 1b Interim Data Accepted as a Late-Breaker Poster at The International Liver Congress™ (EASL)
March 28, 2018 at 5:30 AM EDT
INDIANAPOLIS and SAN FRANCISCO, March 28, 2018 (GLOBE NEWSWIRE) -- 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 live biotherapeutics for disorders associated with the microbiome, today announced the publication of a late-breaker abstract and planned poster presentation of the Phase 1b clinical trial of ABI-H0731 evaluating safety, tolerability and antiviral activity in subjects with chronic HBV at The International Liver Congress™, the Annual Meeting of the European Association for the Study of the Liver (EASL) being held April 11-15, 2018, in Paris. The abstract includes the preliminary data available from 49 healthy volunteers and patients at the time of submission (February 2018). At EASL, the company intends to present an expanded dataset including three healthy subject cohorts (n=30) and three HBV patient cohorts (n>30) treated with ABI-H0731.
“We are pleased to report that initial results of our ongoing Phase 1b study of ABI-H0731 show an attractive safety profile and significant antiviral potency in both HBeAg positive and negative patients, with viral DNA reductions increasing with increasing dose levels,” said Richard Colonno, PhD, Assembly’s executive vice president and chief scientific officer of virology operations. “An important study objective is to identify the minimal dose that produces maximum efficacy of ABI-H0731. We believe we have identified the dose level sufficient to suppress cccDNA establishment and move forward into Phase 2a proof of concept studies this summer.”
Initial patient data from the ongoing Phase 1b study indicate that ABI-H0731 demonstrates potent antiviral activity with once daily dosing for 28 days, is generally safe and well tolerated, and exhibits increasing plasma exposures with increasing dose. At 100 mg per day, the lowest dose tested, HBV declines of 1.3 and 2.2 log10 IU/mL were observed in HBeAg positive and negative patients (respectively). Declines up to approximately 4 logs in HBeAg negative patients were observed following administration of 400 mg per day. HBV RNA reductions were generally proportional to reductions of plasma HBV DNA. No serious adverse events (AEs) and no dose limiting laboratory toxicities were observed. A single Grade 3 treatment-emergent AE (TEAE) leading to drug discontinuation was seen in one patient at the 400 mg dose, otherwise all TEAEs were mild (Grade 1) and/or unrelated to study drug. Over 60 healthy volunteers and patients have been dosed to date, with no dose limiting side effects.
Poster #LBP-012
Title: Interim safety, tolerability pharmacokinetics, and antiviral activity of ABI-H0731, a novel core protein allosteric modulator, in healthy volunteers, and non-cirrhotic viremic subjects with chronic hepatitis B
Date: Thursday, April 12-14, 2018
Time:9:00 am – 5:00 pm CET
The abstract is expected to be posted in the online congress program: https://ilc-congress.eu |
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发表于 2018-3-30 22:41
