Image Source: Voice of Healthcare
Sun Pharma and Israel's Moebius Medical have announced impressive new results from their worldwide Phase 2b MM-II clinical trial of a new non-opioid intra-articular injection for pain of knee osteoarthritis. The study, reported at EULAR 2024, demonstrates a single 3mL intra-articular dose of MM-II delivered meaningful, sustained pain relief lasting up to 26 weeks versus placebo.
Highlights:
Sustained Efficacy: Weeks 12 through 26, a higher percentage of patients treated with MM-II had at least a 50% decrease in pain associated with knee osteoarthritis compared with placebo and used less rescue medication.
Favorable Safety Profile: MM-II had a safety profile similar to placebo, with minimal rates of treatment-emergent adverse reactions and equal rates of injection site reactions.
Novel Mechanism: MM-II has a proprietary suspension of large, empty, multilamellar liposomes aimed at lowering joint friction and wear, providing an alternative to opioids for osteoarthritis pain relief.
Regulatory Momentum: MM-II received Fast Track designation from the U.S. FDA, speeding up its development and approval based on its ability to fill a significant unmet need in osteoarthritis therapy.
Next Steps: Sun Pharma and Moebius Medical are now planning Phase 3 confirmatory trials and seeking a CE Mark for MM-II in the European Union, signaling global ambitions for this innovative therapy.
Expert Endorsement: Abhay Gandhi, CEO of Sun Pharma North America, highlighted the significant unmet need for osteoarthritis therapies, emphasizing MM-II’s potential to transform pain management for millions suffering from joint pain worldwide.
These innovations place MM-II as a highly promising, safe, and long-lasting alternative to current osteoarthritis remedies, poised to redefine the treatment landscape for individuals with knee pain.
Sources: Economic Times, Sun Pharma Press Release, Pharmaceutical Commerce
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