Benzinga | Sep 13, 2021 06:33AM EDT

MIMEDX Announces Top-Line Results From Interim Analysis Of Six-Month Efficacy Data For Phase 2B Trial For KOA Did Not Meet Primary Endpoints

Phase 2B Knee Osteoarthritis (KOA) Study Top-line Interim Results Demonstrate Varied Efficacy Signals between Patient Cohorts



Company to Pursue Phase 3 KOA Confirmatory Studies

Initial Review of Phase 3 Plantar Fasciitis Trial Data Does Not Support a Biologics License Application (BLA) Filing at This Time, Pending Further Analysis

MARIETTA, Ga., Sept. 13, 2021 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (NASDAQ:MDXG) ("MIMEDX" or the "Company"), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced top-line results from two late-stage musculoskeletal clinical trials of the Company's micronized dehydrated Human Amnion Chorion Membrane (mdHACM): a Phase 2B clinical trial for the treatment of Knee Osteoarthritis (KOA) and a Phase 3 clinical trial for the treatment of Plantar Fasciitis (PF).

Top-line results from an interim analysis of the six-month efficacy data for the Phase 2B clinical trial for KOA did not meet primary endpoints, but did reveal varied efficacy signals between patient cohorts evaluated pre- and post- a blinded interim analysis performed in mid-2019, prompting the Company to plan for confirmatory efficacy studies for the KOA indication. The Phase 3 PF study did not meet its primary endpoint, and the Company will not pursue a BLA for this indication at this time. Throughout both studies, the mdHACM product was found safe and well-tolerated.

Timothy R. Wright, MIMEDX Chief Executive Officer, commented, "These data, once examined thoroughly and reviewed with the U.S. Food and Drug Administration (FDA), will help guide our path forward, and merit additional clinical analysis as we pursue novel therapeutic solutions for patients with significant unmet needs. As a pioneer in amniotic tissue technology, our investigational studies further the science and our understanding of what is possible, and enable us to consider next-generation treatments for these painful and debilitating conditions. There is considerable market demand for safe and effective alternatives to reduce pain, improve function, and modify disease, and the potential positive signal within the KOA trial provides opportunity to build on these learnings and pursue additional studies. We look forward to further discussions with the FDA under the Regenerative Medicine Advanced Therapy (RMAT) process, and reviewing our next steps for continued clinical study of PURION(r) Processed mdHACM as a platform for regenerative medicine."