Israeli-Indian Osteoarthritis Therapy Gets FDA Fast Track Designation

An Israeli-Indian treatment for knee pain caused by osteoarthritis has received Fast Track designation by the US Food and Drug Administration – a status granted to developing therapies that address unmet and urgent medical needs. 

The novel MM-II treatment being developed by Tel Aviv-based Moebius Medical and Sun Pharma of Mumbai involves using liposomes (fats) to reduce friction on the knee joint, thereby easing joint pain. 

The two companies are currently preparing to enter Phase 3 clinical trials for MM-II, after data from a randomized, controlled, Phase 2b study showed that a single injection of the therapy provided greater pain relief than a placebo for up to 26 weeks.  

“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,” said Moebius Medical CEO Moshe Weinstein. 

“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, senior vice president and head of global development at Sun Pharma.