A boost for Mesoblast (ASX:MSB) with the company announcing positive results from a Phase 3 trial of MPC-150-IM in patients with moderate to advanced chronic heart failure.
According to the company, its allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM was successful in the pre-specified interim futility analysis of the efficacy endpoint in the trial's first 270 patients.
It is expected that the trial will enrol approximately 600 patients in total.
The trial’s Independent Data Monitoring Committee (IDMC) also told the company they had no safety concerns relating to MPC-150-IM and formally recommended that the trial should continue as planned.
Dr Emerson C. Perin, Director, Research in Cardiovascular Medicine and Medical Director, Stem Cell Center at the Texas Heart Institute, and a lead investigator on the ongoing Phase 3 trial, said: "It is very pleasing to see that this large and rigorously conducted Phase 3 trial of Mesoblast's cell therapy was successful in the pre-specified interim futility analysis for the trial's efficacy endpoint in the first 270 patients. Advanced heart failure is a very serious and life-threatening disease, and there is an urgent need to develop a safe and effective new therapy for these patients that may halt or reverse disease progression and prevent the high associated mortality.”
According to Mesoblast Chief Executive, Silviu Itescu, “Passing this interim futility analysis for MPC-150- IM is an important milestone for Mesoblast and our cardiovascular disease program. This validates our strategy and our prioritization of this valuable program.”
The trial is currently being conducted across multiple study sites in the US and Canada. It is evaluating MPC-150-IM in adult patients with moderate to advanced New York Heart Association (NYHA) Class II/III chronic heart failure with left ventricular systolic dysfunction.
The trial’s primary efficacy endpoint is a comparison of recurrent non-fatal heart failure-related major adverse cardiac events (HF-MACE) in moderate to advanced CHF patients receiving either MPC-150-IM by catheter injection into the damaged left ventricular heart muscle or sham control.