Sun Pharmaceutical Industries and Moebius Medical have announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MM-II (Large Liposomes of DPPC and DMPC) for the treatment of osteoarthritis knee pain. This designation aims to accelerate the development and review of the novel non-opioid therapy. Planning for confirmatory Phase 3 clinical trials for MM-II is currently underway.
The FDA's Fast Track program is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs, potentially bringing new medicines to patients earlier. Companies with FTD-designated investigational products benefit from more frequent interactions with the FDA during clinical development, potentially leading to accelerated approval and priority review.
Marek Honczarenko, MD, PHD, Senior Vice President, Head Global Development at Sun Pharma, stated, "As we enter Phase 3 development, we are very encouraged by the FDA's decision to grant Fast Track designation to MM-II and recognize its potential to fill an unmet medical need for patients suffering from Osteoarthritis."
Moshe Weinstein, CEO of Moebius Medical, added, "This Fast Track Designation, which will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II, and follows our recently released Phase 2b data, which showed MM-II's potential to provide effective and durable treatment for patients with knee pain of Osteoarthritis."
About MM-II
MM-II is a novel non-opioid product that utilizes a proprietary suspension of large, empty, multilamellar liposomes. These liposomes are designed to reduce friction and wear on the joint, thereby alleviating joint pain. Data from a randomized, controlled, Phase 2b study (NCT04506463) demonstrated that a single intra-articular injection of 3mL of MM-II provided greater pain relief than placebo for up to 26 weeks. These results were recently presented at EULAR 2024. Sun Pharma and Moebius Medical are jointly developing this product and have announced plans to initiate a Phase 3 clinical program and seek a CE Mark for the product in the European Union.
Osteoarthritis: A Significant Unmet Need
Osteoarthritis (OA) is the most common chronic degenerative joint disease, characterized by progressive wear of joint cartilage. Clinical manifestations of OA in the knee include pain in and around the joint and limited joint motion. Due to the limited capacity of joint cartilage for self-healing, OA is among the most challenging joint diseases to treat, and currently, no cure exists. Current treatments primarily focus on reducing pain and improving the function of the affected joints. Global estimates indicate that OA affects over 100 million people, with symptomatic OA afflicting more than 30 million Americans. Loss of joint function resulting from this condition is a major cause of work disability and reduced quality of life.
