Image Analysis Group to Provide Imaging Strategy and Advanced Imaging Analytics in Support of MIMEDX’s Knee Osteoarthritis Clinical Trial Program
MARIETTA, Ga., June 15, 2022 (GLOBE NEWSWIRE) — MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a transformational placental biologics company, today announced a collaboration agreement with Nordic Bioscience Clinical Development A/S (NBCD), a world-class Contract Research Organization (CRO) specializing in Osteoarthritis (OA) clinical trials. Image Analysis Group, an expert imaging company, will also provide advanced tools to detect the potential for the Company’s placental biologic injectable, micronized dehydrated Human Amnion Chorion Membrane (mdHACM), to act as a Disease Modifying Osteoarthritis Drug (DMOAD) and potentially moderate the progression of OA. The Company plans to initiate its registrational Knee Osteoarthritis (KOA) clinical trial program later this year, using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and WOMAC Function as co-primary endpoints..
“We have significant evidence that mdHACM injected into the knees of people with OA provides lasting pain relief and improves function, and we believe it has potential as a DMOAD. MIMEDX has discovered how to preserve the remarkable healing properties of placental membranes when we produce mdHACM, and we have demonstrated that it contains many proteins that influence the biology of cartilage-forming cells and reduce inflammation. We believe these active proteins contribute to the striking, long-lasting benefits we have seen in patients receiving a single injection of mdHACM into their osteoarthritic knee. Following an extensive review and selection process, we are very excited to have world-class partners who are at the forefront of advancing meaningful medicines; working in collaboration accelerates our ability to gather quality data for our future Biologics License Application (BLA), and our potential to bring tremendous benefit for people living with OA.” said Robert B. Stein, M.D., Ph.D., MIMEDX President, Regenerative Medicine & Biologics Innovation.
David Mason, M.D., MIMEDX Chief Medical Officer, added, “NBCD has well-established expertise in the field of OA and a proven track record of conducting clinical studies of the highest quality to help advance drug development. They have worked with numerous biopharmaceutical companies to support clinical studies of treatments for KOA in various stages of clinical development, and their approach to operationalizing clinical trials can greatly streamline patient recruitment and accelerate study initiation and enrollment in our upcoming registrational studies.”
Jeppe Ragnar Andersen, NBCD Chief Executive Officer, said, “We are excited to be working with MIMEDX’s mdHACM technology and very glad to be engaged with them to drive their registrational studies forward.”
As MIMEDX’s selected CRO, NBCD will provide full operational support for the upcoming KOA clinical trial program, helping identify and select clinical trial sites and manage patient recruitment and enrollment. In addition, they will oversee clinical trial site monitoring, data management, and statistical analysis and reporting activities. Image Analysis Group will partner with MIMEDX and NBCD to incorporate state-of-the-art imaging techniques and analytic approaches the Company plans to utilize in its KOA clinical trial program.
“IAG offers robust regulatory-required state-of-the-art and exploratory imaging techniques to assess joint health in OA, both qualitatively and quantitatively, enabling early detection and evaluation of the potential for various interventions to modify the course of the disease. By deploying robust patient-centric strategies to understand the variability in those afflicted with OA, we can help reduce irregularities in clinical trials and better assess OA progression and possible DMOAD activity. IAG has a long-standing history of working with leading global sponsors in OA clinical trials, and we are looking forward to working with MIMEDX to assess the potential of mdHACM to modify the progression, course, and patient impact of knee OA” commented Olga Kubassova, Ph.D., Chief Executive Officer, Image Analysis Group (IAG).
The Company’s Phase 2B KOA clinical study results reported last year demonstrated a statistically significant and clinically meaningful improvement in WOMAC Pain at three and six months, respectively (p=0.032 and p=0.009), WOMAC Function (p=0.046 and p=0.009), and WOMAC Total (p=0.038 and p=0.008) for the Pre-Interim Analysis Cohort of 190 patients. These results were observable compared to a substantial placebo response noted in the patient cohort injected with saline. Root-cause analysis determined that the potency of the investigational product faded as it aged, and an intense examination of study results identified this factor as the primary difference in clinical responses observed between the Pre-Interim Analysis Cohort of 190 patients, dosed with newer investigational product, and the Post-Interim Analysis Cohort of 256 patients, dosed with older investigational product. MIMEDX believes it has taken appropriate steps to address these issues and ensure our investigational product can deliver the robust efficacy noted in the first portion of the Phase 2B KOA clinical trial.
About MIMEDX
MIMEDX is a transformational placental biologics company, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare. As a pioneer in placental tissue engineering, we have both a commercial business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a promising late-stage pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions. We derive our products from human placental tissues and process these tissues using our proprietary methods, including the PURION® process. We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts. MIMEDX has supplied over two million allografts, through both direct and consignment shipments. For additional information, please visit www.mimedx.com.
About Image Analysis Group (IAG)
IAG, Image Analysis Group is a unique partner to life sciences companies. IAG leverages expertise in medical imaging and the power of Dynamika™ – our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner. IAG provides early drug efficacy assessments, smart patient recruitment and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes. IAG bio-partnering takes a broader view on asset development bringing R&D solutions, operational breadth, radiological expertise via risk-sharing financing and partnering models.
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