Assembly Biosciences, Inc. reports developments for a clinical-stage biotechnology business focused on small-molecule therapeutics for serious viral diseases. Its recurring updates center on investigational antiviral candidates for herpes simplex virus, hepatitis delta virus and hepatitis B virus, including helicase-primase inhibitors ABI-5366 and ABI-1179, the HDV entry inhibitor ABI-6250 and the HBV capsid assembly modulator ABI-4334.
Company news also covers clinical data presentations, financial results, research and collaboration revenue, the Gilead collaboration and licensing activity, and equity financing transactions that support pipeline development.
Assembly Biosciences (ASMB) reported promising interim results from two Phase 1 clinical trials for its HBV core inhibitors ABI-H3733 and ABI-4334. In the 50 mg cohort of ABI-H3733, six of eight patients achieved HBV DNA levels below quantification by day 21, marking a mean reduction of 3.1 logs. The ABI-4334 trial indicated a favorable pharmacokinetic profile supporting once-daily dosing. Both studies observed no serious adverse events, showcasing safety. A second cohort for ABI-H3733 is ongoing, with data expected in Q1 2023.
Assembly Biosciences (Nasdaq: ASMB) has initiated a Phase 1a clinical trial for its investigational core inhibitor ABI-4334, aimed at treating chronic hepatitis B virus (HBV). The trial, which has begun dosing healthy volunteers, evaluates the safety, tolerability, and pharmacokinetics of 4334. This next-generation treatment shows significantly enhanced potency against cccDNA formation compared to earlier inhibitors. Chronic HBV affects about 296 million people globally, leading to serious liver diseases. The trial results will support future development phases for 4334.
Assembly Biosciences (ASMB) announced its Q3 2022 financial results, revealing a net loss of $23.1 million ($0.48 per share). The company initiated a Phase 1a trial for ABI-4334, its next-generation core inhibitor, and plans to report Phase 1b data for ABI-H3733 by year-end. Research expenses decreased to $18.1 million due to the discontinuation of some projects. Cash reserves stand at $108.7 million, expected to fund operations until mid-2024. The company expanded its pipeline with new programs targeting genital herpes and transplant-associated herpesviruses.
Assembly Biosciences (Nasdaq: ASMB) presented new virology data at the AASLD conference, showcasing advancements in its hepatitis B virus (HBV) therapeutic candidates. Key highlights include the nanomolar potency of ABI-4334, a core inhibitor, and progress on a new class of small molecule entry inhibitors targeting HBV and HDV. The data supports ABI-4334's advancement into Phase 1 clinical studies. Additionally, research on interferon-alpha receptor agonists indicates potential for improved tolerability and long-lasting antiviral effects. The company remains committed to developing curative therapies for chronic HBV patients.
Assembly Biosciences, Inc. (Nasdaq: ASMB) announced four poster presentations at the AASLD The Liver Meeting® from November 4-8, 2022, in Washington, DC. This includes two late-breaking presentations showcasing preclinical data for ABI-4334, a next-generation core inhibitor targeting hepatitis B virus (HBV). The company plans to initiate a Phase 1a trial for ABI-4334 within H2 2022. Additional presentations will focus on their viral entry inhibitor and the ongoing Phase 2 study of vebicorvir. These findings demonstrate the potential of Assembly Bio's innovative virology portfolio.
Assembly Biosciences announced the retirement of John G. McHutchison as CEO effective end of 2022. He will remain on the Board of Directors, chairing the Science & Technology Committee. Jason A. Okazaki, currently the President and COO, has been elected to succeed McHutchison as CEO. Okazaki, who joined Assembly Bio in 2020, played a key role in the company's strategic direction and clinical operations. The Board expresses confidence in Okazaki's leadership to advance the company's mission in developing therapies for hepatitis B virus.
Assembly Biosciences (Nasdaq: ASMB) is set to host a research webcast on August 31, 2022, from 1:30-2:30 PM PT, featuring two innovative small molecule programs targeting viral diseases. Notable speakers include CEO John McHutchison and Nobel laureate Sir Michael Houghton. The first program focuses on a unique antiviral for herpes simplex virus type 2, while the second advances a pan-herpes antiviral for serious viral infections post-transplant. The webcast will be accessible live and via replay on their website.
Assembly Biosciences (ASMB) reported its Q2 2022 financial results, highlighting a cash position of $128.6 million, funding operations until mid-2024. The company initiated a Phase 1b trial for next-generation core inhibitor ABI-H3733 and announced the discontinuation of vebicorvir's development. R&D expenses increased to $17.8 million, while the net loss was $24.5 million, or $0.51 per share. Additionally, a new small molecule interferon-α receptor agonist research program was launched, aiming for improved tolerability in HBV treatments.
Assembly Bio announces the discontinuation of clinical development for vebicorvir (VBR), its first-generation core inhibitor, based on ineffective interim efficacy data from ongoing trials. The focus will shift to next-generation core inhibitors ABI-H3733 and ABI-4334, which have shown significantly higher potency in preclinical studies. The company will undergo organizational restructuring, reducing its workforce by approximately 30%, thus extending its cash runway into the first half of 2024. Initial data from the ABI-H3733 trial is expected in H2 2022.
Assembly Biosciences (Nasdaq: ASMB) reported promising advancements in its investigational HBV core inhibitor programs ABI-H3733, ABI-4334, and vebicorvir (VBR) during the International Liver Congress 2022.
Key data highlights include:
- ABI-H3733 shows improved pharmacokinetics in a new tablet formulation.
- ABI-4334 demonstrates significant potency against HBV cccDNA formation.
- VBR, under Phase 2 studies, exhibits enhanced antiviral effects when combined with entecavir.
Assembly aims to deliver innovative therapies for the 296 million people affected by HBV worldwide.