AskBio's Viralgen to Supply Commercial-Scale Drug Product for REGENERATE-PD Phase II Trial in Parkinson's Disease
AskBio announced on April 20, 2026, that its subsidiary Viralgen will supply commercial-scale ametefgene parvec (AB-1005) using a next-generation manufacturing process for the REGENERATE-PD Phase II trial.
This follows an FDA IND amendment, enabling advancement of the trial in the US with high-purity product from Viralgen's facility.
REGENERATE-PD is a randomized, double-blind, surgery-controlled Phase II trial evaluating intraputaminal AB-1005 in 45-75-year-olds with moderate-stage Parkinson's disease, enrolling ~127 participants across Germany, Poland, UK, and US.
First participants randomized in Germany; trial currently enrolling in Poland, UK, and US.
AB-1005 has received FDA RMAT, Fast Track, Japanese SAKIGAKE, and UK Innovation Passport designations for Parkinson's disease.