Alachua, Fla.-based AxoGen is adding 50 patients and five new centers to the Recon study of Avance, a human allograft designed to bridge severed nerves without a second surgical site. A planned, blinded interim analysis by an independent statistician triggered the expansion, based on data from the first 80 patients used to calculate the size of each treatment arm. AxoGen said the analysis did not look at variability between the cohorts or at interim results.
The FDA approved the expansion to 220 patients April 19; enrollment at the trial’s existing 20 centers is slated to resume and recruitment to begin at new sites during the “next few months,” the company said. The study should be fully enrolled by the end of summer 2020, AxoGen said.
AXGN shares slipped by as much as 4% in pre-market trading today, but had recovered somewhat to $20.57, down -1.3%, as of about 10:50 Eastern.
Avance is already sold in the U.S., but AxoGen is hoping to move the product to a biologics license based on data from Recon, which enrolled its first subject in June 2015.