Fast Track Designation for MM-II in Osteoarthritis Knee Pain Announced by Sun Pharma and Moebius Medical

Sun Pharma and Moebius Medical Limited have announced that the U.S. Food and Drug Administration (FDA) has awarded Fast Track designation to MM-II, a treatment for osteoarthritis knee pain. MM-II is composed of large liposomes of DPPC and DMPC, intended to alleviate joint pain by reducing friction and wear. The partners are now preparing for Phase 3 clinical trials to confirm its efficacy.

The FDA's Fast Track program aims to accelerate the development and review of drugs that address serious conditions and unmet medical needs, potentially allowing new medicines to reach patients sooner. Benefits of this designation include more frequent interactions with the FDA and the possibility of expedited approval or priority review.

Marek Honczarenko, Senior Vice President of Global Development at Sun Pharma, expressed optimism about the Fast Track designation, noting it could meet a significant need for osteoarthritis patients. Moshe Weinstein, CEO of Moebius Medical, highlighted that this designation is a critical milestone for MM-II. He pointed to recent Phase 2b data showing the treatment's potential to provide effective, long-lasting relief from knee pain caused by osteoarthritis.

MM-II is a novel, non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes. These liposomes are designed to reduce joint friction and wear, thereby alleviating pain. Data from a randomized, controlled Phase 2b study showed that a single 3mL intra-articular injection of MM-II provided more pain relief than a placebo for up to 26 weeks. These findings were recently presented at EULAR 2024. Sun Pharma and Moebius Medical have announced plans to begin Phase 3 clinical trials and seek a CE Mark for MM-II in the European Union.

Osteoarthritis is the most common chronic degenerative joint disease, marked by the progressive wear of joint cartilage. Knee osteoarthritis symptoms include joint pain and limited motion. Due to the inability of joint cartilage to self-heal, osteoarthritis remains a challenging condition to treat, with no cure currently available. Treatments focus on pain reduction and improving joint function. Globally, osteoarthritis affects more than 100 million people, with over 30 million symptomatic cases in the United States. The loss of joint function due to osteoarthritis is a significant cause of work disability and reduced quality of life.

Sun Pharmaceutical Industries Limited is a leading global specialty generics company with a significant presence in specialty, generics, and consumer healthcare products. It is the largest pharmaceutical company in India and a major player in the U.S. and emerging markets. Sun Pharma's global specialty portfolio includes innovative products in dermatology, ophthalmology, and onco-dermatology, contributing to over 18% of the company's sales. The company's operations are vertically integrated, ensuring high-quality medicines trusted by healthcare professionals and consumers in more than 100 countries. Its manufacturing facilities are located across six continents, and its workforce is composed of individuals from over 50 nations.

Moebius Medical is a clinical-stage biotechnology company focused on developing novel pain relief treatments for osteoarthritis. Founded in 2008 within the RAD Biomed Accelerator, Moebius Medical leverages patent-protected technology licensed from Yissum, the Technology Transfer Company of the Hebrew University; T3, the Technology Transfer arm of the Technion Institute; and Hadasit, the Technology Transfer company of Hadassah Medical Center. In 2016, Moebius Medical entered a joint collaboration with Sun Pharma to develop MM-II.