Sun Pharma and Moebius Medical’s MM-II Receives FDA Fast Track Status for Osteoarthritis Treatment

Sun Pharmaceutical Industries Limited, in collaboration with Israel-based Moebius Medical Limited, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for MM-II, a novel treatment targeting osteoarthritis knee pain. MM-II is formulated using large liposomes of DPPC and DMPC, which have shown potential in addressing the unmet medical requirements of patients suffering from osteoarthritis.

The FDA’s Fast Track program is designed to accelerate the development and review of therapies that treat serious conditions and fulfil unmet medical needs. This designation offers several benefits, including more frequent interactions with the FDA throughout the clinical development process, and the potential for expedited approvals or priority reviews.

With the FTD in place, planning for the Phase 3 clinical trials for MM-II is now underway, marking a significant step forward in the journey toward bringing this innovative treatment to patients. The Phase 3 trials will serve as confirmatory studies, providing further evidence of the efficacy and safety of MM-II in managing osteoarthritis knee pain.

This collaboration between Sun Pharma and Moebius Medical demonstrates their shared commitment to developing groundbreaking treatments for patients with osteoarthritis, potentially offering a new option for pain management.

Commenting on this development, the MD, PhD, Senior Vice President of Head Global Development at Sun Pharma, Marek Honczarenko, said, “As we enter Phase 3 development, we are very encouraged by the FDA’s decision to grant Fast Track designation to MM-II and recognise its potential to fill an unmet medical need for patients suffering from Osteoarthritis.”

Moshe Weinstein, CEO of Moebius Medical, stated, “This Fast Track Designation, which will

enable the 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 MMII’s potential to provide effective and durable treatment for patients with knee pain of Osteoarthritis.”

On September 6, 2024, the share price of Sun Pharmaceutical Industries Ltd opened at ₹1,819.55, touching the day’s high at ₹1,850.00, as of 12:31 PM on the NSE.

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