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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.
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Assembly Biosciences (Nasdaq: ASMB) has shared Phase 1a clinical data for its HBV core inhibitor, ABI-4334, which shows promising efficacy against viral replication and cccDNA formation. The company is actively considering partnering options for its core inhibitor portfolio, aiming to advance the development of these therapies. In addition, Assembly Bio is prioritizing its antiviral pipeline, including ABI-5366 for high-recurrence genital herpes, with plans to enter clinical trials in the first half of 2024. The financial outlook remains strong, with an estimated cash runway extending into Q3 2024. CEO Jason Okazaki highlighted the need for longer-duration studies to validate the efficacy of core inhibitors. Overall, the results suggest a strong foundation for future development in HBV treatments.
Assembly Biosciences, Inc. (Nasdaq: ASMB) updated its progress on investigational hepatitis B virus (HBV) core inhibitors ABI-3733 and ABI-4334. The company is prioritizing ABI-4334 based on its superior potency and clinical profile while pausing ABI-3733 due to observed toxicity concerns. Preliminary data from ABI-3733’s Phase 1b trial showed significant viral suppression in patients. Financially, the company reported a net loss of $93.1 million for 2022, an improvement from $129.9 million in 2021. As of December 31, 2022, cash reserves were $91.6 million, projected to fund operations into mid-2024.
Assembly Biosciences (ASMB) has announced the selection of ABI-5366 as a development candidate for its long-acting HSV-2 helicase inhibitor program. This selection marks a significant advancement since the company expanded its research focus beyond hepatitis B. The drug, designed for long-acting administration, shows favorable pharmacokinetics and potential for at least monthly dosing. Current HSV-2 therapies are partially effective, and ABI-5366 aims to enhance adherence and efficacy. The company plans to file with the FDA in the first half of 2024 and is eager to present more data at scientific conferences this year.
Carver Biosciences, a Boston-based biotech firm focused on CRISPR/Cas13 antivirals, has established its Scientific Advisory Board (SAB). Dr. Cameron Myhrvold will chair the SAB, with Dr. Uri Lopatin, Dr. Olivia Merkel, and Dr. Neville Sanjana joining as members. Dr. Lopatin brings significant experience from founding Assembly Biosciences (NASDAQ:ASMB) and Pardes Biosciences (NASDAQ:PRDS), having raised over $600 million for novel therapies. The new board aims to enhance Carver's pipeline and advance its clinical programs.
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.