Osteoarthritis candidate MM-II shows durable pain relief in global phase 2b study: Sun Pharma

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.”

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