Antios Therapeutics and Assembly Biosciences Announce Clinical Collaboration Agreement to Evaluate the Combination of ATI-2173 and Vebicorvir in Patients with Chronic Hepatitis B Virus Infection
MENDHAM, N.J., and SOUTH SAN FRANCISCO, Calif., October 19, 2021 – Antios Therapeutics, Inc. and Assembly Biosciences, Inc. (Nasdaq: ASMB) today announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial will evaluate ATI-2173, Antios’ investigational proprietary active site polymerase inhibitor nucleotide (ASPIN), vebicorvir (VBR), Assembly Bio’s investigational lead core inhibitor candidate, and tenofovir disoproxil fumarate, a nucleotide reverse transcriptase inhibitor.
The multi-center, double-blinded, placebo-controlled cohort will evaluate the safety, pharmacokinetics, and antiviral activity of this all-oral triple combination. This cohort is expected to start in the first half of 2022 and will enroll 10 treatment naïve or off-treatment HBeAg negative or positive patients in a 12-week treatment study.
“Antios is focused on developing a functional cure for people living with chronic HBV. ATI-2173 has, to date, demonstrated a generally well-tolerated safety profile, leveraging a unique ASPIN mechanism in clinical development to empower combination therapy. Ultimately, ATI-2173 has the potential to become a cornerstone of a once-daily curative regimen in combination with other agents, like vebicorvir, for the treatment of chronic HBV,” said Gregory Mayes, Chief Executive Officer of Antios.
“Our collaboration with Antios emphasizes our commitment to evaluating the backbone of our core inhibitors plus a nucleos(t)ide analogue in combination with other mechanisms to treat HBV, a cause of chronic infection that can lead to a higher risk of death from cirrhosis and liver cancer,” said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Bio. “The commitment that we and Antios share to pursue finite and curative therapies for HBV unites us in these research efforts and offers hope for patients.”
About ATI-2173
ATI-2173, Antios Therapeutics’ lead once-daily, oral drug candidate for treating HBV, is an investigational phosphoramidate prodrug of clevudine monophosphate. ATI-2173 has the potential, if approved, to become the cornerstone of a curative HBV regimen. It is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development and its mechanism of action is designed to be complementary to other approaches that also seek to achieve a functional cure. ATI-2173 is currently in Phase 2 clinical development. The SAVE-1 (Sustained Anti-Viral Efficacy) trial is an ongoing, double-blind, randomized, placebo-controlled study of 30 adult patients designed to assess the safety and efficacy of 25 and 50 mg doses of ATI-2173 daily for 90 days in combination with tenofovir disoproxil fumarate (TDF) compared with TDF plus ATI-placebo (control) in chronic HBV-infected subjects.
About Vebicorvir, Assembly Bio’s Lead HBV Core Inhibitor
Assembly Bio’s HBV portfolio includes three investigational small molecule candidates, all of which are HBV core inhibitors that target multiple steps of the HBV replication cycle. In Phase 2 clinical trials, first-generation core inhibitor vebicorvir (VBR) administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy demonstrated a favorable safety profile and led to greater viral suppression of both HBV DNA and HBV pgRNA than NrtI therapy alone. VBR is advancing in multiple Phase 2 combination studies.