Advances Potential for Use of Micronized Dehydrated Human Amnion Chorion Membrane (mdHACM) as a Safe and Effective Treatment Option
On Track to Advance Planned Analyses and Announce Top-Line Data in Plantar Fasciitis, Achilles Tendonitis and Knee Osteoarthritis in Q3 2021
MARIETTA, Ga., April 19, 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 that the last patients have completed their last clinical visits in two late-stage Investigational New Drug (IND) trials: Phase 3 studies of AmnioFix® Injectable (micronized dehydrated Human Amnion Chorion Membrane (mdHACM)) as a potential treatment for Plantar Fasciitis and Achilles Tendonitis. In addition, all clinical effectiveness endpoint visits have been completed in a Phase 2B study of mdHACM as a potential treatment for Knee Osteoarthritis. With the completion of these patient visits, the Company will begin the planned review and statistical analyses of data from all three trials.
“Completion of the Phase 2B study for mdHACM as a treatment for Knee Osteoarthritis marks an extraordinary milestone,” said Alfred Gellhorn, M.D., Adjunct Associate Professor of Clinical Rehabilitation and Director of Sports Medicine, Weill Cornell Medicine. “There is a tremendous unmet need for safe and effective treatment options for Knee Osteoarthritis. The osteoarthritis community has long recognized that current treatment options are painfully insufficient. The benefit of a novel therapeutic option in this setting for both patients and clinicians cannot be overstated.”
"These studies are designed to prove the clinical efficacy and safety of AmnioFix Injectable in treating frustrating chronic conditions," said Stuart Miller, M.D., Principal Investigator, Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, and Assistant Professor, Department of Orthopaedic Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland. “The prior Phase 2B Plantar Fasciitis study has helped establish the product’s safety profile, and I believe these further studies may demonstrate its effectiveness in battling inflammatory conditions. As a physician committed to advancing patient care, I would welcome having additional treatment options that could potentially address the pain and quality of life issues my patients face on a daily basis.”
Timothy R. Wright, MiMedx Chief Executive Officer, added, “These trials play key roles in our late-stage AmnioFix Injectable pipeline, and with last patient visits complete across the three trials, we will now lock the databases, conduct the appropriate statistical analyses, and request meetings with the U.S. Food and Drug Administration (FDA) to review the findings. We anticipate announcing top-line results of all three trials this summer, have commenced planning efforts to initiate our Phase 3 clinical trial for Knee Osteoarthritis, and plan to file a Biologics License Application (BLA) for Plantar Fasciitis in the first half of 2022. Although we do not anticipate pursuing a BLA for Achilles Tendonitis, we expect to glean valuable safety data for the AmnioFix Injectable product from that trial. On behalf of MiMedx, I would like to express our sincere gratitude to all the patients, families and physicians who participated in these important studies critical to our submissions to FDA for approvals for the therapeutic use of amniotic tissues.”
The typical steps for obtaining FDA approval of a BLA to market a biological product in the United States include performance of two adequate and well-controlled clinical trials in accordance with Good Clinical Practices to establish the safety and efficacy of the product for each indication, along with the development of purity, potency and identity tests to demonstrate consistency and reliability of the manufacturing process through a chemistry, manufacturing and control program. Submission to the FDA of a BLA for marketing the product includes, among other things, reports of the outcomes and full data sets of the clinical trials, and proposed labeling and packaging for the product. In addition, the satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced is required to assess compliance with FDA’s Current Good Manufacturing Practice (CGMP) regulations, to assure that the facilities, methods and controls are adequate to ensure the product’s identity, potency, quality and purity.
About the Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee TrialThis trial, the first randomized clinical study of a micronized dehydrated Human Amnion/Chorion Membrane (mdHACM) Injection in the Treatment of Knee Osteoarthritis (KOA), is a Phase 2B, prospective, double-blinded, randomized controlled trial of the mdHACM injection as compared to saline placebo injection in the treatment of osteoarthritis of the knee. Trial enrollment was planned to include 466 patients between the ages of 21 to 80 years, with a diagnosis of osteoarthritis defined as grade 1 to 3 on the Kellgren Lawrence grading scale and a Visual Analog Scale (VAS) for Pain score greater than 45. Due to a lower-than-expected number of study participant dropouts, and with an adequate number of patients meeting the required time in study to assess the primary endpoint, the final number randomized will be 447 patients.
The primary efficacy endpoints include change from baseline in VAS at 90 days, change from baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 days, and incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 365 days. Secondary endpoints include: change from baseline in VAS at 180 days and change from baseline in WOMAC at 180 days. The WOMAC Index has become a standard study metric in KOA studies and its use has been extensively validated.
The blinded efficacy visits for this study are complete, with the 12-month safety visit follow up as requested by FDA scheduled to compete in October 2021. The Company intends to initiate a Phase 3 study of mdHACM injection in the treatment of Knee Osteoarthritis in Q3 2021, after an end of Phase 2 meeting with FDA, and planning for this effort is underway.
About Knee OsteoarthritisOsteoarthritis (OA) is by far the most common joint disease – millions of adults experience pain and decreased quality of life every day because of joint destruction caused by osteoarthritis. Osteoarthritis is responsible for a staggering public health and economic impact: more than 242 million people worldwide currently suffer from symptomatic OA of the knee and hip; 45% of all people have a lifetime risk of developing OA of the knee; and OA is responsible for $71 billion in lost earnings annually in the U.S. Although knee replacement is an option for those with advanced knee arthritis, it carries significant risks, and current treatment algorithm, including oral anti-inflammatory medications, cortisone injections, and hyaluronic acid injections, are limited in the amount of relief it can provide. Anti-inflammatories have negative cardiovascular effects and injected steroids cause further joint degeneration.
About the Micronized dHACM Injectable for the Treatment of Plantar Fasciitis TrialThis study is a Phase 3, prospective, double-blinded, randomized controlled trial of micronized dehydrated Human Amnion Chorion Membrane (mdHACM) injection as compared to saline placebo injection in the treatment of plantar fasciitis. The trial enrolled 277 patients between the ages of 21 and 79 years, with an investigator-confirmed diagnosis of plantar fasciitis for greater than or equal to one month (30 days) and less than or equal to 18 months. Patients were required to have a Visual Analog Scale (VAS) Pain scale of greater than or equal to 45 mm at randomization and be receiving conservative treatment for greater than or equal to 1 month (30 days), including any of the following modalities: Rest, Ice, Compression, Elevation (RICE); stretching exercises; NSAIDs or orthotics. The primary endpoints are change in VAS for Pain at 90 Days and incidence of related adverse events at 180 days, serious adverse events and unanticipated events during the first 12 months post-injection. Secondary endpoints include self-reported responses to the Foot Function Index – Revised (FFI-R) at 90 days.
This study follows a Phase 2B prospective, single‐blinded, randomized controlled trial of 145 patients, which demonstrated a statistically significant reduction in VAS score for pain and an improvement in Foot Function Index-Revised (FFI-R) score. At the 3‐month follow‐up, the mean VAS score was reduced by 76% for patients in the Treatment Group compared with a 45% reduction for the Control Group (p