Assembly Biosciences Reports Positive Interim Results from Phase 1b Clinical Study of Long-Acting Helicase-Primase Inhibitor Candidate ABI-5366 Showing Reductions in Viral Shedding Rate and Genital Lesion Rate in Recurrent Genital Herpes
– 94% reduction in HSV-2 shedding rate and 98% reduction in high viral load shedding rate, both statistically significant, observed in cohort evaluating 350 mg weekly oral dose compared to placebo over 29-day evaluation period –
Related Questions
What is the expected timeline to initiate Phase 2 trials for ABI‑5366?
How does the 94% reduction in HSV‑2 shedding compare to the efficacy of existing herpes treatments?
Were any safety or tolerability signals observed in the 350 mg weekly dose cohort?
How will the interim Phase 1b results affect Assembly Biosciences' near‑term stock price?
What is the total addressable market for a long‑acting therapy in recurrent genital herpes and what revenue potential does it represent for ASMB?
What regulatory pathway and timeline does the FDA anticipate for a new class of herpes therapeutics?
How might analysts adjust their coverage and consensus estimates for ASMB in response to these results?
What are the projected costs for continued clinical development and will they extend the company's cash runway?
Will the novel helicase‑primase mechanism provide a competitive advantage over standard nucleoside analogs?
Does Assembly Biosciences have any existing partnership or licensing agreements that could be impacted by these data?
Are there plans to evaluate ABI‑5366 in other HSV‑1/HSV‑2 indications or broader antiviral indications?
How might the once‑weekly oral dosing regimen influence patient adherence versus current daily antivirals?