As per the notification on 21 December 2020, the US-FDA has cleared their IND application to start a global Phase IIb clinical trial of MM-II, a new candidate for alleviating pain in patients suffering from knee osteoarthritis. This randomized, multi-center, placebo-controlled, double-blind, dose-ranging trial aims to explore the safety and efficacy of various doses of MM-II in patients with symptomatic knee osteoarthritis.

MM-II is a new non-opioid intra-articular injection that uses the physical properties of proprietary liposomes and has an innovative mechanism-of-action to yield substantial improvements in knee pain. Comprehensive pre-clinical work has illustrated that the lubricating properties of MM-II, which work to lower the joint friction and wear of cartilage, and a first-in-human trial has indicated the tolerability and ability of this new candidate to mitigate knee pain in individuals with osteoarthritis.

A decline in pain from baseline as estimated based on Western Ontario and McMaster Universities' Osteoarthritis Index (WOMAC) pain score at 12 weeks is the primary outcome. The study recruitment of 312 individuals is anticipated to start in the United States, Asia, and Europe by the end of the year 2020, and the high-quality data is anticipated to be available in the year 2022. Investigators are really enthusiastic to move MM-II back into the clinic, a vital step towards bringing this much-needed remedy to osteoarthritis patients.