MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
A second long-acting injectable antipsychotic using MedinCell's technology has received FDA IND* clearance to initiate clinical activities. A first-in-human study is expected to start in the second half of 2019.
“We have achieved our goal of having at least one clinical trial authorization per year”, stated Christophe Douat, CEO of MedinCell. “This third product reaching clinical stage confirms the high versatility of our BEPO technology and the strong know-how of our team in successfully customizing the technology for different compounds.”
mdc-TJK is one of three antipsychotic products in development based on MedinCell’s technology. The others include a research product in clinical Phase 3 studies and another in preclinical stage.
For more information about MedinCell and our portfolio, visit our website at www.medincell.com
*An Investigational New Drug Application (IND) is a required filing with the US Food and Drug Administration (FDA) prior to administering an investigational drug product to humans.
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.