MedinCell S A : announces successful completion of patient enrollment in the Phase 3 study of F14 (mdc-CWM), a first-in-class therapy for localized pain relief after Total Knee Replacement

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• Enrolment is complete following the randomization of 151 patients across seven centers in the US
• The study was initiated in November 2022 and is proceeding as planned with efficacy results anticipated in Q1 2024
• F14 (mdc-CWM) is a sustained-release formulation of the non-steroidal anti-inflammatory drug (NSAID), celecoxib, administered intraarticularly at the end of Total Knee Replacement surgery (TKR)
• F14 (mdc-CWM) aims to facilitate patient recovery from TKR surgery by providing post-operative pain relief by addressing inflammation, thereby accelerating improvement in knee function, and potentially decreasing the need for addictive opioids
• F14 (mdc-CWM) is the third product using MedinCell's proprietary technology BEPO® to reach, or to have completed, a Phase 3 clinical trial

MedinCell today announces that its partner, Arthritis Innovation Corporation (AIC), who conducts and finances all development activities of F14 (MedinCell codename: mdc-CWM), has completed the patient enrollment in the first of two Phase 3 clinical studies of F14 in patients undergoing total knee replacement (TKR). F14 (mdc-CWM) is a sustained-release formulation of the non-steroidal anti-inflammatory drug (NSAID), celecoxib, administered into the intra-articular space at the end of TKR surgery.
Dr. Wayne Marshall, CEO at AIC said: "TKR is a highly invasive surgery that results in prolonged knee pain and inflammation that last for many weeks, but current single-administration, post-TKR analgesics are limited to only hours or days in their durations of efficacy. F14 was designed and developed to reduce that surgical pain for much longer by addressing inflammation, accelerating functional improvement, and potentially reducing opioid consumption for TKR patients. Completing patient enrollment in our Phase 3 study brings us closer to demonstrating that F14 is a first-in-class therapy that will meet that major therapeutic gap around TKR recovery."
151 patients have been enrolled in the multicenter, randomized, double-blind Phase 3 study designed to evaluate the efficacy and safety of a single administration of F14 (mdc-CWM) for post-operative analgesia in patients undergoing unilateral TKR. The primary analysis will be conducted following a 3-month follow-up period, and top-line data are anticipated in Q1 2024. More study information can be found at: https://www.clinicaltrials.gov/study/NCT05603832?term=Total%20Knee%20Replacement&intr=F14%20%5C(celecoxib%5C)&rank=3

Dr. Richard Malamut, Chief Medical Officer at MedinCell said: "F14 could have a major impact as it could offer physicians a simple, yet much-needed therapeutic solution, to manage patients' post-operative pain following TKR. Furthermore, today in the US, 15% of TKR patients become chronic opioid users and thus, a decrease in opioid consumption due to lower post-operative pain would be a positive factor in the long-lasting opioid crisis."