MiMedx: Phase 3 PF Study Fails To Meet Primary Endpoint; To Pursue Phase 3 KOA Confirmatory Studies

(RTTNews) - MiMedx Group, Inc. (MDXG) reported top-line results from two late-stage musculoskeletal clinical trials of its micronized dehydrated Human Amnion Chorion Membrane: a phase 2B clinical trial for the treatment of Knee Osteoarthritis and a phase 3 clinical trial for the treatment of Plantar Fasciitis. The phase 3 Plantar Fasciitis study did not meet its primary endpoint, and the company will not pursue a Biologics License Application for this indication at this time.

Top-line results from an interim analysis of the six-month efficacy data for the phase 2B trial for Knee Osteoarthritis did not meet primary endpoints. However, the trial did reveal varied efficacy signals between patient cohorts evaluated pre- and post- a blinded interim analysis performed in mid-2019. As a result, the company plans for confirmatory efficacy studies for the Knee Osteoarthritis indication.

MiMedx Group plans to meet with the FDA to determine the appropriate path forward toward the initiation of phase 3 clinical trials in Knee Osteoarthritis. The company now believes that two phase 3 studies in Knee Osteoarthritis will be required to file a Biologics License Application.

Shares of MiMedx Group were down 48% in pre-market trade on Monday.