MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
MedinCell’s (Paris:MEDCL) CEO Christophe Douat states: “We are happy to report that the mdc-CWM program, partnered and in phase 2 clinical trial, is progressing well and on schedule.”
As a reminder, recruitment was capped by MedinCell’s partner at 20 patients for the active phase 2 clinical study in April 2019. All participants have completed their 3-month follow-up visit this summer. The analysis of the data is being completed by our partner and its subcontracted clinical research organization. 12-month trial completion is scheduled on March 2020. Our partner plans to meet with FDA in the meantime to discuss the current findings and how to progress in the next trial moving forward.
The product is for management of postoperative pain in participants undergoing unilateral total knee replacement. The study’s primary endpoints include pain measures and post-surgical opioid consumption. MedinCell’s CEO Christophe Douat adds: “While total knee replacement surgery leads to decreased pain in most patients, a sizable minority continue to experience severe pain and consume opioids chronically after it. It is one of the surgeries were patients use the most opioids and an estimated 15 % of these, or 150 000 patients per year, become new persistent opioid users for many months after surgery. A decrease in pain and opioid consumption should be viewed as a very positive factor in the current opioid crisis, which is one of the highest priorities of the FDA.”
Note: As programs based on MedinCell’s technology move into more advanced phases, data, analysis and conclusions may only be communicated in the future on an ad hoc basis to preserve clinical study integrity and competitive positioning.
mdc-CWM is the second most advanced program based on MedinCell’s technology. MedinCell has three programs in clinical development and two in preclinical development.
For more information about MedinCell and our portfolio, visit our website at www.medincell.com.
MedinCell is a clinical stage pharmaceutical company that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. Based in Montpellier, MedinCell currently employs more than 130 people representing over 25 different nationalities.