Clinical trialsCompany release

Precision BioSciences reports Phase 1 hepatitis B gene-editing data, plans global Phase 2

🇺🇸 Precision Biosciences Inc (DTIL) · Thu 05 Nov 2026

New ELIMINATE-B results for PBGENE-HBV show undetectable pgRNA and cccDNA reductions at the 0.4 mg/kg dose, with no dose-limiting toxicities or serious adverse events reported.

Precision BioSciences has announced fresh Phase 1 results for PBGENE-HBV, its gene-editing candidate for chronic hepatitis B. The data come from the ELIMINATE-B study and will be given as a late-breaking oral presentation at AASLD The Liver Meeting on 8 November 2026. The company's release is dated 5 November.

At the 0.4 mg/kg dose, all six evaluable patients reached undetectable levels of pgRNA, according to the company. Paired biopsies showed reductions in cccDNA of roughly 1 to 1.5 log at that dose.

On safety, Precision BioSciences reports no dose-limiting toxicities and no serious adverse events at 0.4 mg/kg. The full source text was not available to VigiEye, so details such as study design, follow-up duration, and results at other dose levels are not covered here.

The company says the findings support moving into a global Phase 2 study. No start date, trial design or regulatory timelines were included in the information available.

What it means for your team

  • The data are a company announcement ahead of a conference presentation; detailed methods and full safety listings will be needed to assess them.
  • Regulatory teams should watch for Phase 2 design and any scientific advice or trial authorisation steps across the US and Europe.
  • Pharmacovigilance teams should note that the safety claim rests on a small group at one dose level and an early-phase setting; longer follow-up will matter for a gene-editing therapy.

Company's press release (SEC filing): Precision Biosciences Inc ↗

Article written by VigiEye from the official source (Precision Biosciences Inc). Claims are the company's own. AI-assisted; check the source before acting.

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