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 (Nasdaq: ASMB) has dosed the first participant in its Phase 1b clinical trial for ABI-4334, a next-generation capsid assembly modulator (CAM) targeting chronic hepatitis B virus (HBV) infection. The trial aims to evaluate the safety, pharmacokinetics, and efficacy of ABI-4334 over a 28-day period. Interim data is expected by the end of 2024. ABI-4334 has shown promising preclinical results with strong antiviral activity and is optimized to inhibit HBV DNA replication and prevent cccDNA formation. Chronic HBV is a leading cause of chronic liver disease and liver transplants, making this study important for potential therapeutic advancements.
Assembly Biosciences announced the closure of $12.6 million in equity financings from Armistice Capital and Gilead Sciences. The funds will support Assembly's antiviral portfolio, with clinical data readouts expected for ABI-5366 and ABI-4334 in the coming years.
The equity financings involve the sale of common stock and warrants at $15.46 per share with warrants exercisable at $17.00. These transactions extend Assembly's cash runway into Q1 2026 and maintain Gilead's 19.9 percent ownership, with an option to increase up to 29.9 percent.
Assembly intends to use the proceeds for general corporate purposes and further advance its clinical candidates, with significant near-term milestones anticipated.
Assembly Biosciences has initiated a Phase 1a/b clinical trial for ABI-5366, a new helicase-primase inhibitor targeting herpes simplex virus (HSV). The Phase 1a trial involves single ascending doses in healthy participants, with interim data expected by Q3 2024. Phase 1b will start by the end of the year with multiple ascending weekly doses in patients with recurrent genital herpes, with interim data expected in the first half of 2025. ABI-5366 has shown strong potential in preclinical studies, potentially offering a long-acting treatment for HSV-1 and HSV-2. Existing treatments are and not fully effective, highlighting the need for new therapeutic options in this area.
Assembly Biosciences showcased new preclinical data for ABI-6250, an orally bioavailable hepatitis D virus (HDV) entry inhibitor, at the EASL Congress 2024. The data underline ABI-6250's potential to block HDV from entering cells, targeting the NTCP bile acid transporter with high selectivity. The preclinical results showed effective inhibition of HDV infection and NTCP-mediated bile acid uptake, supporting once-daily oral dosing. Clinical trials are expected to begin by the end of 2024. Chronic HDV is a severe viral hepatitis form, leading to liver complications and potential death. ABI-6250 promises to be a significant therapeutic innovation in viral hepatitis treatment.
Assembly Biosciences (Nasdaq: ASMB) will present preclinical data from its HSV and HDV therapeutics at the International Herpesvirus Workshop (July 13-17, 2024) and EASL Congress 2024 (June 5-8, 2024). Data for ABI-5366 and ABI-1179, targeting recurrent genital herpes, will be featured in one oral and two poster presentations. ABI-6250, aimed at treating chronic hepatitis D, will be presented as a poster. The company anticipates starting clinical trials for ABI-5366 mid-year and for ABI-1179 and ABI-6250 by the end of 2024.
Assembly Biosciences, Inc. (Nasdaq: ASMB) reported financial results for Q1 2024, including regulatory clearances for Phase 1 trials for ABI-5366 targeting recurrent genital herpes and ABI-4334 in chronic HBV infection. The company highlighted upcoming clinical milestones, abstract acceptance for ABI-6250 at EASL CongressTM 2024, and financial results showing $113.0 million in cash as of March 31, 2024. Revenues from collaborative research were $5.8 million, with research and development expenses at $11.9 million and a net loss of $9.1 million for Q1 2024.
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