Michael Barbella, Managing Editor06.16.22
MiMedx Group Inc. has contracted Nordic Bioscience Clinical Development A/S (NBCD) to run registrational trials for its placental biological knee osteoarthritis treatment.
Image Analysis Group 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 disease's progression. MIMEDX plans to begin its knee osteoarthritis (KOA) clinical trial 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," said Robert B. Stein, M.D., Ph.D., MIMEDX president of Regenerative Medicine & Biologics Innovation. "MIMEDX has discovered how to preserve the healing properties of placental membranes when we produce mdHACM, and we have demonstrated it contains many proteins that influence the biology of cartilage-forming cells and reduce inflammation. We believe these active proteins contribute to the 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 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.”
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.
"NBCD has well-established expertise in the field of OA and a proven track record of conducting clinical studies to help advance drug development," said David Mason, M.D., MIMEDX chief medical officer. "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.”
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, NBCD 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 uses in its KOA clinical trial program.
“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," NBCD CEO Jeppe Ragnar Andersen said.
Osteoarthritis (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 characteristic of OA. More than 300 million people worldwide currently suffer from symptomatic OA of the knee and hip; 45 percent of all people have a lifetime risk of developing OA of the knee; and OA is responsible for approximately $71 billion in lost earnings annually in the United States. There are currently over 17.5 million people in the United States with KOA, and this number is growing. The early onset of the disease is growing as age, obesity, and sports injuries make their contribution. Many of these people will face progressive disability or require total knee replacement surgery. Although knee replacement is an option for those with advanced OA, it carries significant risks, and the current non-surgical treatment algorithm for these patients, including oral anti-inflammatory medications, cortisone injections, and hyaluronic acid injections, are limited in the amount of relief they can provide.
"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," said Olga Kubassova, Ph.D., CEO of Image Analysis Group. "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 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."
MIMEDX is a 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, the company has both a commercial business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a late-stage pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions. Its products are derived from human placental tissues and these tissues are processed using proprietary methods, including the PURION process. MIMEDX has supplied more than 2 million allografts, through both direct and consignment shipments.
NBCD is a contract research organization (CRO) dedicated to clinical drug development and research in osteoarthritis. NBCD specializes in design and execution of clinical trials within both pain and DMOAD compounds for osteoarthritis. NBCD is an expert in placebo response mitigation and osteoarthritis study design. NBCD support biotech and pharmaceutical clients in advancing osteoarthritis compounds through all clinical development phases. NBCD has more than 25 years of experience in osteoarthritis biomarkers and clinical trials. Combining the background in preclinical research and clinical research enables NBCD to help provide a faster and smarter evaluation the potential clinical viability of drug candidates.
Image Analysis Group, an imaging expert company, helps to accelerate novel drug development by using the right analytical tools and modern trial infrastructure. This includes bringing artificial intelligence, machine learning, and smart image analysis methods to ensure speed and cost-effectiveness, while delivering true insights about your mechanism of action and patients’ response, in real-time.
Image Analysis Group 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 disease's progression. MIMEDX plans to begin its knee osteoarthritis (KOA) clinical trial 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," said Robert B. Stein, M.D., Ph.D., MIMEDX president of Regenerative Medicine & Biologics Innovation. "MIMEDX has discovered how to preserve the healing properties of placental membranes when we produce mdHACM, and we have demonstrated it contains many proteins that influence the biology of cartilage-forming cells and reduce inflammation. We believe these active proteins contribute to the 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 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.”
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.
"NBCD has well-established expertise in the field of OA and a proven track record of conducting clinical studies to help advance drug development," said David Mason, M.D., MIMEDX chief medical officer. "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.”
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, NBCD 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 uses in its KOA clinical trial program.
“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," NBCD CEO Jeppe Ragnar Andersen said.
Osteoarthritis (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 characteristic of OA. More than 300 million people worldwide currently suffer from symptomatic OA of the knee and hip; 45 percent of all people have a lifetime risk of developing OA of the knee; and OA is responsible for approximately $71 billion in lost earnings annually in the United States. There are currently over 17.5 million people in the United States with KOA, and this number is growing. The early onset of the disease is growing as age, obesity, and sports injuries make their contribution. Many of these people will face progressive disability or require total knee replacement surgery. Although knee replacement is an option for those with advanced OA, it carries significant risks, and the current non-surgical treatment algorithm for these patients, including oral anti-inflammatory medications, cortisone injections, and hyaluronic acid injections, are limited in the amount of relief they can provide.
"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," said Olga Kubassova, Ph.D., CEO of Image Analysis Group. "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 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."
MIMEDX is a 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, the company has both a commercial business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a late-stage pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions. Its products are derived from human placental tissues and these tissues are processed using proprietary methods, including the PURION process. MIMEDX has supplied more than 2 million allografts, through both direct and consignment shipments.
NBCD is a contract research organization (CRO) dedicated to clinical drug development and research in osteoarthritis. NBCD specializes in design and execution of clinical trials within both pain and DMOAD compounds for osteoarthritis. NBCD is an expert in placebo response mitigation and osteoarthritis study design. NBCD support biotech and pharmaceutical clients in advancing osteoarthritis compounds through all clinical development phases. NBCD has more than 25 years of experience in osteoarthritis biomarkers and clinical trials. Combining the background in preclinical research and clinical research enables NBCD to help provide a faster and smarter evaluation the potential clinical viability of drug candidates.
Image Analysis Group, an imaging expert company, helps to accelerate novel drug development by using the right analytical tools and modern trial infrastructure. This includes bringing artificial intelligence, machine learning, and smart image analysis methods to ensure speed and cost-effectiveness, while delivering true insights about your mechanism of action and patients’ response, in real-time.