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Assembly Biosciences (ASMB) filed an 8-K reporting interim Phase 1b results for its long-acting HSV helicase-primase inhibitor ABI-5366.
The 350 mg once-weekly oral dose achieved a 94% reduction in HSV-2 viral shedding versus placebo (p<0.01) over 29 days, exceeding the study’s 80-85% target. Secondary endpoints also improved: 94% lower genital-lesion rate and 98% reduction in high-viral-load samples (p<0.05). The drug was well-tolerated at doses up to 350 mg weekly, and its pharmacokinetic profile supports both once-weekly and potential once-monthly dosing.
With these data, Assembly plans to move directly into Phase 2 preparations while finishing the Phase 1b trial’s monthly-dosing cohort. Chronic toxicology studies are complete and expected to support longer-term dosing in Phase 2.
What this filing says, in plain language
Assembly Biosciences is an early-stage biotech working on several antiviral drug programs. As of June 30, 2025, it held about $24.0 million in cash and $51.0 million in marketable securities (approximately $75.0 million total). Management says that amount is not sufficient to fund operations beyond one year, and the company has substantial doubt about its ability to continue as a going concern unless it secures more funding. The company recognized collaboration revenue from Gilead of $9.6 million this quarter ($19.0 million for the six months) and has deferred revenue from that collaboration of about $53.96 million, which supports near-term work. The company reported a net loss of $10.2 million this quarter ($19.0 million six months) and used $40.2 million in cash for operations in the first half of 2025. Clinically, Assembly reported positive early human data for two long-acting herpes drug candidates (5366 and 1179), topline antiviral results for its HBV candidate (4334), and ongoing Phase 1 work for its HDV entry inhibitor (6250). These results show scientific progress but the company has no approved products and needs additional financing to continue development.
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