FDA Grants MM-II Fast Track Designation for Treatment of Osteoarthritis Knee Pain

The non-opioid drug can induce healing of joint cartilage in patients with osteoarthritis.

The FDA granted fast track designation (FTD) to MM-II, a non-opioid product that uses proprietary suspension of liposomes to relieve joint pain, for the treatment of osteoarthritis (OA) knee pain, according to a news release from Sun Pharma and Moebius Medical Limited.¹

Man suffering from knee pain sitting on a sofa.

Osteoarthritis is the most common degenerative joint disease. | Image credit: © Dragana Gordic | stock.adobe.com

Data supporting the use of MM-II in patients with OA were recently presented at European Alliance of Associations for Rheumatology 2024 in June. At that conference, results from a randomized, controlled, phase 2b clinical trial (NCT04506463) were showcased, showing that a single intra-articular injection of 3 mL of MM-II provided greater pain relief than placebo for up to 26 weeks.^1,2,4

In the trial, patients experienced a greater than 50% improvement in knee pain from weeks 12 to 26 after treatment with MM-II. This positive data supports the FDA’s issuing of a FTD, which will facilitate development and review of the therapy and could be eligible for an accelerated regulatory approval process.¹

“As we enter phase 3 development, we are very encouraged by the FDA’s decision to grant fast track designation to MM-II and recognize its potential to fill an unmet medical need for patients suffering from [OA] osteoarthritis,” Marek Honczarenko, MD, PhD, senior vice president and head of global development at Sun Pharma, said in the news release.¹

Characterized by the progressive wear and tear of joint cartilage, OA is the most common chronic degenerative joint disease, afflicting more than 30 million Americans and 100 million globally. The condition is difficult to treat and cure due to the inability of joint cartilage to self-heal; therefore, the current focus of treatments is to reduce pain and improve joint function in areas affected.¹

“This fast Ttack designation, which will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II, and follows our recently released phase 2b data, which showed MMII’s potential to provide effective and durable treatment for patients with knee pain of [OA] osteoarthritis,” Moshe Weinstein, CEO of Moebius Medical, said in the news release.¹

About the Trial

Trial Name: Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis

ClinicalTrials.gov ID: NCT04506463

Sponsor: Sun Pharmaceutical Industries Limited

Completion Date: August 10, 2022

Pharmacists are a key player in ensuring patients with OA receive proper pain management. Tools should be utilized to identify patients in the community who may have OA or be at risk for developing the condition. Additionally, pharmacists should ensure that patients are literate in their health care education regarding this condition, as patients who are aware of their pain and what to expect are more likely to see advice regarding managing symptoms.³

Medication adherence is also a major factor in treating patients with OA. If MM-II were to reach regulatory approval status in the future, ensuring that patients are consistently adhering to the drug protocol will lead to better quality of life for this population for which no cure exists.^1,3

"Given the limitations of many current therapies, there is an urgent need for more therapeutic treatment options for patients with painful osteoarthritis. Data from the 3mL dose of MM-II in this trial demonstrate MM-II's potential to offer durable and meaningful pain relief with good tolerability,” Philip G Conaghan, MB, PhD, FRACP, FRCP, professor of musculoskeletal medicine at the University of Leeds, said in a statement upon the release of the clinical trial preliminary results.²

REFERENCES

1. Sun Pharma, Moebius Medical. Sun Pharma and Moebius Medical announce fast track designation granted for MM-II for the treatment of osteoarthritis knee pain. News Release. Released September 6, 2024. Accessed September 16, 2024. https://sunpharma.com/wp-content/uploads/2024/09/Press-Release-Sun-Pharma-and-Moebius-Medical-Announce-Fast-Track-Designation-Granted-for-MM-II.pdf

2. Moebius. Oral presentation at EULAR 2024 of data from global phase 2b clinical trial demonstrates durability of pain relief after a single injection of MM-II in patients with painful knee osteoarthritis (OA). News Release. Released June 14, 2024. Accessed September 16, 2024. https://www.prnewswire.com/il/news-releases/oral-presentation-at-eular-2024-of-data-from-global-phase-2b-clinical-trial-demonstrates-durability-of-pain-relief-after-a-single-injection-of-mm-ii-in-patients-with-painful-knee-osteoarthritis-oa-302172939.html

3. Sawtelle L. Osteoarthritis management: Determine what patients know, then fill in gaps. Pharmacy Times. Published May 25, 2022. Accessed September 16, 2024. https://www.pharmacytimes.com/view/osteoarthritis-management-determine-what-patients-know-then-fill-in-gaps

4. ClinicalTrials.gov. Efficacy and safety of MM-II for treatment of knee pain in subjects With symptomatic knee osteoarthritis. National Library of Medicine. Last updated August 29, 2024. Accessed September 16, 2024. https://clinicaltrials.gov/study/NCT04506463