Precision BioSciences reports Phase 1 data showing pgRNA loss and cccDNA reduction, plans Phase 2
Precision BioSciences announced that its hepatitis B gene‑editing candidate PBGENE‑HBV achieved undetectable pre‑genomic RNA and 1‑ to 1.5‑log drops in liver cccDNA at a 0.4 mg/kg dose in a Phase 1 study of 25 patients. The therapy was well tolerated with no dose‑limiting toxicities across 59 administrations. The company will move the program into a global Phase 2 trial in 2027 and will discuss the results in a webcast on 9 Nov 2026.
Why it matters
The firm says the data support advancing to a global Phase 2 study to evaluate cure rates after a finite treatment course. Investors may reassess the company's valuation based on the prospect of a first‑in‑class cure for chronic hepatitis B.
Key facts
- 1PBGENE‑HBV was tested at a 0.4 mg/kg dose, which the company selected as the go‑forward dose for Phase 2. stocktitan.net
- 2All evaluable patients at the 0.4 mg/kg dose showed undetectable pgRNA, with 100 % durability in those followed for six months or more. sec.gov
- 3Liver biopsies from two patients treated at 0.4 mg/kg revealed approximately 1‑log (10‑fold) and 1.5‑log (35‑fold) reductions in cccDNA. stocktitan.net
- 4The safety profile was manageable, with no dose‑limiting toxicities observed across 59 administrations in 25 patients. sec.gov
- 5The data cutoff for the Phase 1 results was 28 Sep 2026, covering 25 patients and 59 administrations. sec.gov
- 6Precision will host a webcast for investors and key opinion leaders on 9 Nov 2026 at 8:00 a.m. ET to present the data. stocktitan.net
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.