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Assembly Biosciences Announces Oral Presentation at 2018 AASLD
By GlobeNewswire, October 02, 2018, 07:05:00 AM EDT
SAN FRANCISCO, Oct. 02, 2018 (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 company will have an oral presentation of the full data set from the Phase 1b study of ABI-H0731 at the upcoming American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting®), being held November 9-13 in San Francisco.
The oral presentation at AASLD will review final results of the Phase 1b study in patients with chronic hepatitis B (HBV) infection, including safety, tolerability and pharmacokinetics of ABI-H0731 (or ‘731), as well as quantitative changes in HBV DNA, RNA and viral antigens. ABI-H0731 was safe and well tolerated, with dose dependent antiviral effects at doses ranging from 100 to 400 mg given orally once daily, and RNA declines paralleled the observed DNA declines. The company presented interim results of the study at the Annual Meeting of the European Association for the Study of the Liver (EASL) in April.
"We are pleased with the final results from the Phase 1b study, with viral load responses and a safety profile that solidly support our clinical strategy in the two Phase 2a trials currently underway in HBV patients," said Uri Lopatin, M.D., Chief Medical Officer. "Both trials are evaluating oral '731 at 300 mg once daily in combination with standard of care nucleos(t)ide therapy, with one trial enrolling treatment-experienced HBV patients with suppressed viral loads and the other enrolling treatment-naïve patients."
In July, the Company received FDA Fast Track Designation for ABI-H0731 and expects to report interim data from the Phase 2a trials during the first half of 2019. Assembly also plans to expand its clinical HBV pipeline later this year with the initiation of a Phase 1 study on its second, highly potent core inhibitor, ABI-H2158.
Oral Presentation
Title: Final Results of a Phase 1b 28-Day Study of ABI-H0731, a Novel Core Inhibitor, in Non-Cirrhotic Viremic Subjects with Chronic Hepatitis B
Session: Parallel 8: Novel Therapies for HBV
Room: 157/160, Moscone Center, North and South Buildings
Date:Sunday, November 11, 2018
Time:10:30am PT
Presenter: MF Yuen, MD, PhD, Chief of Division of Gastroenterology and Hepatology, Queen Mary Hospital, Hong Kong |
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发表于 2018-10-3 13:05
