AxoGen to Expand Enrollment of Phase 3 Study of Avance Nerve Graft

AxoGen (AXGN) said Monday that it has completed the planned interim analysis for its phase 3 RECON study, which will support the submission of a Biologic License Application (BLA) to the Food and Drug Administration for for its Avance Nerve Graft.

Based on the results of the interim analysis, the study’s independent biostatistician recommended continuation of the study with a one-time expansion in enrollment according to a pre-defined sample size re-estimation.

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The study enrollment target will be increased by 50 subjects to a total target of 220. AxoGen may add up to five new study centers, for a total of 25 centers, to support enrollment. Based on the anticipated site start-up and historical study enrollment, AxoGen said it expects to complete enrollment during the summer of 2020.

Avance Nerve Graft is an off-the-shelf processed human nerve allograft intended for the surgical repair of peripheral nerve discontinuities, according to the company.