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For managing knee osteoarthritis
patients, the Investigational New Drug (IND) application to start the MM-II
Phase IIb trial has been cleared by the United States Food and Drug
Administration (US-FDA).
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.
PR Newswire
Moebius Medical Announces FDA Clearance of IND Application for Phase IIb Clinical Trial of MM-II, a Novel Treatment for Knee Osteoarthritis Pain
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