Osteoarthritis candidate MM-II shows durable pain relief in global phase 2b study: Sun Pharma
Osteoarthritis is one of the most common chronic health conditions and a leading cause of pain and disability among adults.
Mumbai: Sun Pharma and Israel-based Moebius Medical Limited have recently announced the topline results of their Phase 2b, randomized, double-blind, placebo-controlled, singleadministration, multiple-dose study evaluating the efficacy and safety of MM-II for the treatment of knee pain in participants with symptomatic knee osteoarthritis (NCT04506463).
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.
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.
The results of the study were presented this past weekend at the 2023 Osteoarthritis Research Society International (OARSI) World Congress on Osteoarthritis held in Denver, CO, US.
Thomas J. Schnitzer, MD, PhD, a rheumatologist and professor of Medicine at Northwestern University, who presented the study results, said that “the dearth of options for treating osteoarthritis, coupled with challenges we face from the reliance on opioids, puts MM-II in a unique position to offer a possible alternative to hyaluronic acid and steroid treatments. The data from this study show that MM-II has the potential to provide durable pain relief for our patients.”
