Moebius Medical Announces Dosing of First Patient in Global Phase IIb Clinical Trial of MM-II, a Novel Treatment for Knee Osteoarthritis Pain

TEL AVIV, Israel, Feb. 16, 2021 /PRNewswire/ -- Israel-based Moebius Medical today announced that the first patient has been dosed in its Phase IIb clinical trial of MM-II, a novel candidate for the treatment of pain in knee osteoarthritis (OA).

The Phase IIb clinical trial, which is expected to enrol approximately 312 subjects across the US, Denmark, and Hong Kong, is a randomized, double-blind, dose-ranging, placebo-controlled study designed to determine the efficacy and safety of various doses of MM-II in subjects with symptomatic knee OA as compared to placebo. The primary endpoint of the study is reduction in pain compared to baseline as measured according to Western Ontario and McMaster Universities' Osteoarthritis Index (WOMAC) A pain score at 12 weeks. Top-line data from the trial is expected to be available in mid-2022.

"The dosing of our first patient in this phase II study is a significant milestone in the development of our lead product," commented Mr. Moshe Weinstein, CEO of Moebius Medical. "We look forward to positive results, which will be a step forward towards bringing this much needed novel solution to millions of osteoarthritis patients."

About Moebius Medical

Moebius Medical is a clinical stage biotechnology company that is developing novel treatments for osteoarthritis. The company's lead product, MM-II, is a novel non-opioid intra-articular injection that leverages the physical properties of proprietary liposomes and an innovative mechanism-of-action to provide sustainable relief of symptomatic knee OA pain. Extensive pre-clinical work has demonstrated MM-II's lubricating properties, which work to reduce joint friction and wear of cartilage, and a first-in-human study has demonstrated MM-II's tolerability and ability to reduce knee pain in OA patients. The product is based on patent-protected technology jointly developed by and licensed from the Hebrew University, the Technion Institute, and Hadassah Medical Center.

Established in 2008 within the RAD Biomed Accelerator, Moebius Medical has been funded by RAD Biomed, PixVine Capital, a Singapore-based early stage VC fund, and Yissum, the technology transfer office of the Hebrew University.

About Osteoarthritis

Osteoarthritis is the most common chronic degenerative joint disease, characterized by progressive wear of joint cartilage. Clinical manifestations of OA in the knee include, but are not limited to, pain in and around the joint and limited joint motion. Due to the inability of joint cartilage to self-heal, OA is among the most challenging joint diseases to treat, and currently no cure exists. The focus of current OA treatments is to reduce pain and improve function of the affected joints. Global estimates of OA exceed 100 million, and symptomatic OA afflicts more than 30 million Americans. Loss of joint function as a result of this condition is a major cause of work disability and reduced quality of life.

Safe Harbor: Statements in this document describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

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