FDA Approves IND of AmnioFix

MiMedx Group announced the company has been notified by the Food and Drug Administration (FDA) that its Investigational New Drug (IND) Phase 2B clinical study for osteoarthritis of the knee may proceed.

The clinical study consists of a Phase 2B, prospective, double-blinded, randomized controlled trial of MiMedx's AmnioFix Injectable (micronized dehydrated Human Amnion Chorion Membrane), compared to saline placebo in the treatment of knee osteoarthritis. The trial will enroll approximately 318 patients and the company expects patient enrollment to commence in the next quarter.

MiMedx announced that it had filed for this IND Phase 2 to be initiated in September 2017. At that time, the company indicated the IND Phase 2 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of osteoarthritis of the knee. The primary efficacy endpoints of this study will be the change in Visual Analog Scale (VAS) score and the change in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index for patients between baseline and Day 90 between the AmnioFix Injectable group versus the placebo-control group. The primary safety endpoint will be the proportion of product-related Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during 12 months following injection in the AmnioFix Injectable group versus the placebo-control group.

"This knee osteoarthritis study is the fourth IND trial conducted by MiMedx for our AmnioFix Injectable. We are pleased to receive the FDA's notification that we can proceed with another IND study in the Orthopedic/Sports Medicine area," Parker H. Petit, CEO, said. "We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders apprised on our future study results. Later this year, we will hold a meeting in New York that will include presentations by MiMedx executives and the physicians involved with our various IND studies to better inform analysts and our shareholders of these important activities."