The primary completion date1 for the pivotal efficacy study to investigate mdc-IRM, an investigational subcutaneous risperidone, was reached on September 30, 2020. The estimated study completion date2 has been moved forward to November 24, 2020 from January 31, 2021.
Phase 3 safety investigations continue with an estimated study completion date scheduled on December 31, 2020.
“We are pleased that mdc-IRM continues to progress through the development process,” stated Christophe Douat, CEO of MedinCell (Paris:MEDCL). “We are excited that the first long-acting injectable antipsychotic using our proprietary technology has reached this Phase 3 clinical milestone. Our partner anticipates having the readout of the trial sometime in Q1 2021.”
mdc-IRM is the most advanced in development of three antipsychotic products based on MedinCell’s technology and is being developed by Teva Pharmaceuticals. There is another investigational product currently in Phase 1 (mdc-TJK), and another in preclinical development (mdc-ANG).
1 The primary completion date is the date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. The primary outcome measure is the most important for evaluating the effect of a treatment.
2 Study completion date is the date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant’s last visit).
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.
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