RMAT and Fast Track Designation
CHAPEL HILL, NORTH CAROLINA / ACCESS Newswire / February 19, 2025 / Doron Therapeutics, a clinical-stage biotechnology company focusing on degenerative musculoskeletal conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to MOTYS™, its lead placental tissue-derived biologic in clinical development for the treatment of symptoms associated with knee osteoarthritis (OA). In addition to RMAT, MOTYS was also granted Fast Track designation (FTD) by FDA.
The RMAT designation program specifically addresses the expedited development and review of promising regenerative medicine therapies with the potential to address unmet medical needs for serious diseases or conditions. RMAT designation provides the benefits of intensive and frequent FDA guidance on efficient development, including the opportunity to discuss the use of intermediate endpoints to support Accelerated Approval. Candidates receiving RMAT designation may also be eligible for expedited review and approval of their Biologics License Application (BLA).
Doron’s RMAT and Fast Track designation requests were supported by the body of preclinical and clinical evidence available on MOTYS, with specific emphasis on the clinical findings from its Phase 2 dose-finding study of 215 patients, which identified durable, dose-dependent effects of MOTYS on pain mitigation and improved functional outcomes (presented at the Osteoarthritis Research Society International (OARSI) World Congress 2024).
“Securing RMAT designation is a significant milestone for MOTYS that underscores the promise of our clinical evidence and the potential for this technology to improve the life of millions of patients whose lives are limited by the symptoms of knee osteoarthritis,” said Alessandra Pavesio, CEO of Doron Therapeutics. “We are very pleased that the FDA has provided us with a pathway for expedited approval of MOTYS and look forward to working in close collaboration with the Agency to bring MOTYS to the patients we serve.”
About OA
OA is the most common joint disorder and cause of chronic disability in the U.S. Prevalence of knee OA continues to grow as a result of an aging population, growing prevalence of obesity, and increased participation in active sports, affecting approximately 14 million Americans ages 25 and older, and nearly eight million under the age of 65. Accounting for more than $185 billion in annual expenditures, OA places a significant burden on the U.S. healthcare system and, with limited therapeutics options available, is the main contributor of the rise in joint replacements.
About MOTYS
MOTYS is a terminally sterilized, off-the-shelf, placental-tissue particulate designed for intra-articular knee injection for the management of symptomatic knee osteoarthritis. MOTYS’s concentrated secrotome, growth factor, and extracellular matrix components are derived from carefully controlled, donated placental tissues, following healthy at-term births.
About Doron Therapeutics
Doron Therapeutics is a clinical-stage biotechnology company focusing on degenerative musculoskeletal conditions. Doron’s lead candidate, MOTYS, includes a host of beneficial growth factors with pre-clinical data that suggests potent anti-inflammatory, tissue-protective and regenerative capabilities pivotal to treating the progressive and degenerative disease of osteoarthritis.
Contact Information
Sarah Caley
Head of Business Development
info@dorontherapeutics.com
SOURCE: Doron Therapeutics Inc.
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