Sun Pharma and Israel-based Moebius Medical have announced that the US Food and Drug Administration (FDA) has granted fast-frack designation (FTD) to MM-II (large liposomes of DPPC and DMPC) for the treatment of osteoarthritis knee pain. Planning for confirmatory Phase 3 clinical trials for MM-II is 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 in order to potentially bring important new medicines to patients earlier. Among other benefits, companies whose investigational products are granted FTD are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review.
“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,” said Marek Honczarenko, MD, PHD, senior vice-president, head, Global Development at Sun Pharma.
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.”
MM-II is a non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes which are intended to reduce friction and wear on the joint and thus relieve joint pain. Data from a randomized, controlled, Phase 2b study (NCT04506463) showed that a single intra-articular injection of 3mL of MM-II provided greater pain relief than placebo for up to 26 weeks and was recently presented at EULAR 2024. Sun Pharma and Moebius Medical, who have been jointly developing this product, have announced plans to initiate a Phase 3 clinical program and to seek a CE Mark for the product in the European Union.
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 but are not limited to, pain in and around the joint and limited joint motion. Due to the inability of joint cartilage to self-heal, OA is among the most challenging joint diseases to treat, and currently, no cure exists.
