Sun Pharma and Israel-based Moebius Medical Limited recently announced the topline results of their Phase 2b, randomized, double-blind, placebo-controlled, single- administration, multiple-dose study evaluating the efficacy and safety of MM-II for the treatment of knee pain in participants with symptomatic knee osteoarthritis (NCT04506463). Designed to guide the Phase 3 US FDA program, this study examined multiple doses of MM-II vs placebo, measuring changes in pain using standard pain measurement instruments, including the weekly average of daily knee pain and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The primary outcome measure was the change from baseline in WOMAC A pain score at Week 12.

The study was conducted across 25 sites in the U.S., Europe, and Asia and enrolled 397 participants. While the study did not achieve statistical significance on the primary outcome measure, it did show meaningful and sustained improvement across several clinical measures. In the target 3 mL dose, the reduction in the WOMAC A pain score from baseline to 12 weeks (primary endpoint) was larger for MM-II 3 mL vs placebo 3 mL (nominal P = 0.047; adjusted for multiplicity, P = 0.085).

MM-II also showed a nominally significant and durable reduction in the weekly average of daily knee pain vs placebo starting at week 6 and enduring through week 26 (nominal P = 0.008 at week 12, P = 0.007 at week 26) for the 3 mL dose. Results of the WOMAC pain and function subscales, patient global assessment scores, use of rescue medication, and responder criteria all showed durable improvements for participants receiving MM-II 3 mL. MM-II was well tolerated with treatment- emergent adverse events reported in 2.6% of MM-II and 2.9% of placebo participants.

Injection site reactions were similar in the treatment and control groups, 1.9% and 2.9%, respectively. MM-II is a novel non-opioid product that consists of a proprietary suspension of large, empty, multilamellar liposomes that lubricate arthritic knee joints, thereby reducing friction and wear, consequently leading to joint pain reduction. Osteoarthritis is one of the most common chronic health conditions and a leading cause of pain and disability among adults.

Global estimates reveal that more than 100 million people are affected by osteoarthritis. More than 20 million people in the US suffer from knee osteoarthritis. The global market for products used for symptomatic relief of knee osteoarthritis pain (such as intra-articular hyaluronic acid) is about $2 billion with a 6.5% compound annual growth rate; the US alone accounts for about 40% of this market.