Medincell and AIC Unveil New Positive Phase 3 Results for mdc-CWM: Major Subgroup Analysis Shows Reduced Pain and Opioid Use, and Accelerated Rehabilitation following Total Knee Replacement
Medincell and AIC Unveil New Positive Phase 3 Results for mdc-CWM: Major Subgroup Analysis Shows Reduced Pain and Opioid Use, and Accelerated Rehabilitation following Total Knee Replacement
MONTPELLIER, France--(BUSINESS WIRE)--Analysis of a major subgroup of patients undergoing a first Total Knee Replacement (TKR), representing over 70% of the trial population (108 out of 151), revealed the following benefits when comparing patients treated with F14/mdc-CWM (n=51) to those in the control group (n=57)1:
- 70% reduction in the number of opioid users at 3 months post-surgery,
- 28% reduction in the total quantity of opioids consumed during the first 3 months post-surgery,
- Lower daily knee pain over the endpoints of 3 and 7 days, 2 and 6 weeks, and 3 months post-surgery,
- Range of motion (ROM) milestone (100 degrees) achieved significantly faster,
- Significant improvements across multiple, independent assessments of pain, inflammation and function.
The analysis of this large subgroup of patients undergoing their first TKR revealed a consistently greater treatment effect compared to the overall study population which also included patients receiving a second TKR.2
This subgroup of patients will be the primary focus of future clinical development, planned for 2025, provided FDA agreement.
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Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable.
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1 Source: F14 Clinical Phase 3 Study (100-CIP02; 2022-2024); Data on file. Arthritis Innovation Corporation - Toronto, Canada; ClinicalTrials.govID NCT05603832
2 Results presented in May 2024; www.medincell.com/wp-content/uploads/2024/05/PR_Medincell_CWM_14052024_EN.pdf
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