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Biopharmaceuticals Orthopaedic FDA

 News Release - December 21, 2020

Moebius Medical Announces FDA Clearance of IND Application for Phase IIb Clinical Trial of MM-II, a Novel Treatment for Knee Osteoarthritis Pain

Treatment leverages proprietary liposomes and first-in-class mechanism-of-action to achieve significant, sustainable pain relief

- Phase IIb study expected to begin enrolling by year-end with initial top-line data anticipated in mid-2022


TEL AVIV, Israel, Dec. 21, 2020 -- (Healthcare Sales & Marketing Network) -- Israel-based Moebius Medical today announced that the US Food and Drug administration (FDA) has cleared their Investigational New Drug (IND) application to initiate a global multi-center Phase IIb clinical trial of MM-II, a novel candidate for the treatment of pain in knee osteoarthritis (OA).

The planned Phase IIb clinical trial, 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 is a reduction in pain from baseline as measured according to Western Ontario and McMaster Universities' Osteoarthritis Index (WOMAC) A pain score at 12 weeks. Enrollment of the trial's 312 subjects is expected to begin in US, Europe and Asia by the end of 2020, and top-line data is expected to be available in mid-2022.

OA is a painful, chronic and progressive joint disease that affects more than 100 million people globally. Symptomatic OA afflicts more than 30 million Americans, and loss of joint function as a result of this condition is a major cause of work disability and reduced quality of life. The focus of current treatment for OA is to reduce pain and improve function of the affected joints.

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.

Mr. Moshe Weinstein, CEO of Moebius Medical, added, "We are very excited to move MM-II back into the clinic, a major step forward towards bringing this much-needed solution to millions of osteoarthritis patients."

The product is based on patent-protected technology that was developed jointly by renown professors from the Hebrew University of Jerusalem, the Technion Israel Institute of Technology and Hadassah Medical Center. The company, which licensed the technology, was established within the RAD Biomed Accelerator, and funded by RAD Biomed, PixVine Capital, a Singapore-based early stage VC fund, and Yissum.

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.

About Moebius Medical

Moebius Medical (www.moebiusmedical.com) is a clinical stage biotechnology company that is developing novel treatments for osteoarthritis. The company's lead product, MM-II, is based on a patent-protected technology licensed exclusively from Yissum, the Hebrew University Technology Transfer Company, T3, the Technology Transfer arm of the Technion Institute, and Hadasit, the Technology Transfer company of Hadassah Medical Center. The technology was borne from the multidisciplinary cooperation between Prof. Yechezkel Barenholz, Prof. Izhak Etsion, and Prof. Dorit Nitzan of these prestigious institutions. The company was established within the RAD Biomed Accelerator, and funded by RAD Biomed, PixVine Capital, a Singapore-based early stage VC fund, and Yissum.

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.


Source: Moebius Medical

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