Assembly Biosciences Announces ABI-H0731 Phase 1b Interim Data Accepted as a Late-Breaker Poster at The International Liver Congress™ (EASL)
“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
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.
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
The abstract is expected to be posted in the online congress program: https://ilc-congress.eu
The information in this press release contains forward-looking statements regarding future events, including statements about the clinical and therapeutic potential of Assembly’s development programs and the timing of clinical trials. Certain forward-looking statements may be identified by reference to a future period or periods or by use of forward-looking terminology such as “progressing,” “designed,” “believe” or “developing.” Assembly intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Assembly are more fully detailed under the heading “Risk Factors” in Assembly's Annual Report on Form 10-K for the year ended
Source: Assembly Biosciences