MiMedx notified by FDA to proceed with Phase 2B IND trial for osteoarthritis
MiMedx has been notified by the FDA that its Investigational New Drug 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, 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. 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 score and the change in Western Ontario and McMaster Universities osteoarthritis index for patients between baseline and Day 90 between the AmnioFix Injectable group versus the placebo-control group.