Pioner plasma full#
Pioner plasma trial#

As reported previously, addition of VBR to entecavir treatment resulted in statistically significant declines in HBV DNA and pgRNA and normalization of ALT levels compared to entecavir treatment alone.

вЂњ Deeper virologic suppression with the addition of vebicorvir, a first-generation hepatitis B core inhibitor, to entecavir correlates with reduced inflammation and fibrosis-4 index in treatment-naГЇve patients with HBeAg positive chronic hepatitis B,вЂќ provides ad hoc analyses from Assembly BioвЂ™s Study 202 in which treatment naГЇve, HBeAg positive patients were randomized in a blinded fashion to receive once a day entecavir either with or without vebicorvir for 24-weeks.

Pioner plasma full#

Additional data in the poster demonstrates an improved activity against core inhibitor binding pocket variants as well as full activity against nucleoside-resistant HBV.ДЇour posters were presented providing clinical updates on the companyвЂ™s core inhibitor candidate VBR, which is currently being evaluated in Phase 2 triple combination studies. These preclinical data also show the compound potently inhibits pgRNA encapsulation resulting in the formation of empty capsid particles, consistent with the activity of Class II core inhibitors. In the poster entitled вЂњ ABI-4334, a novel inhibitor of hepatitis B virus core protein, promotes formation of empty capsids and prevents cccDNA formation by disruption of incoming capsids,вЂќВ preclinical data indicate that 4334 prematurely melts incoming HBV capsids, preventing formation of cccDNA with a single digit nM EC 50. The T2 tablet formulation of 3733 is being evaluated in a recently-initiated Phase 1b study in patients with chronic HBV infection.Д¤334 is a novel investigational core inhibitor with single-digit nanomolar (nM) potency against covalently closed circular DNA (cccDNA) formation and pgRNA encapsidation in vitro. In HBV patients, the 300 mg dose formulated as the new T2 tablet is projected to achieve exposure that is approximately 150- and 29-fold higher than the protein adjusted EC 50 for inhibition of HBV DNA replication and cccDNA formation, respectively.

In preclinical studies, the T2 formulation at 100 mg dose (predicted human equivalent dose 300mg) showed equivalent plasma serum concentration to the liquid formulation. The poster entitled вЂњ Improving the pharmacokinetic profile of the hepatitis B virus core inhibitor ABI-H3733 following oral administration: results from new formulation activities,вЂќВ presents pharmacokinetic data on the new tablet (T2) formulation for 3733. Next-Generation HBV Core Inhibitor Candidates 37 Finally, the variety of data presented on VBR, currently being evaluated in triple combination studies, continues to build upon this compoundвЂ™s antiviral potency and clinical profile.вЂќ

Pioner plasma trial#

Additionally, preclinical data presented for 4334, with its best-in-class potential, demonstrates the candidate's potent activity against both cccDNA formation and pre-genomic RNA (pgRNA) encapsidation, supporting our plans to initiate a Phase 1a trial later this year. вЂњOur enthusiasm for the new tablet formulation of 3733, which is being evaluated in our recently-initiated Phase 1b study, is supported by data presented today demonstrating improved PK parameters preclinically, with plasma levels comparable to the liquid formulation. вЂњWe are excited to present these new data that demonstrate the progress and promising profiles of our next-generation, significantly more potent core inhibitor candidates 37, and that further characterize the profile of VBR,вЂќ said John McHutchison, AO, MD, chief executive officer and president of Assembly Bio. SOUTH SAN FRANCISCO, Calif., J(GLOBE NEWSWIRE) - Assembly Biosciences, Inc.В (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative, investigational therapeutics targeting hepatitis B virus (HBV) and other viral diseases, today announced data from the companyвЂ™s investigational core inhibitor programs ABI-H3733 (3733), ABI-4334 (4334) and vebicorvir (VBR), featured in six poster presentations at the International Liver Congressв„ў, the Annual Meeting of the European Association for the Study of the Liver (EASL) taking place virtually and in London on June 22-26, 2022.