MedinCell announced 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), celebritycoxib, administered into the intra-articular space at the end of TKR surgery. 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 first quarter 2024. 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 first quarter of 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.