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. 

Designed to guide the Phase 3 USFDA 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 US, Europe, and Asia and enrolled 397 participants.

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, a rheumatologist and professor of Medicine at Northwestern University, who presented the study results, said “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.” 

"These encouraging data support MM-II’s potential as a novel therapy for treating patients with osteoarthritis," said Dilip Shanghvi, Managing Director, Sun Pharma. 

“Pain related to osteoarthritis is a significant unmet need and urgently requires new agents which can improve patient outcomes. We believe MM-II has the potential to improve upon currently existing therapies in this space,” added Shanghvi. 

Moshe Weinstein, CEO, Moebius Medical said, “With the durability of pain relief seen in this trial and the overall clean safety profile, MM-II has the potential to be a new option for patients with knee osteoarthritis and an alternative to steroid and hyaluronic acid injections. We look forward to working with our partner Sun Pharma to continue the development and commercialization of this promising product."