Under the trial, Mesoblast carried out a post-hoc analysis in 30 patients who were randomized to receive either placebo or a single administration of 150 million MPCs (MPC-150-IM).
The company found that patients with advanced heart failure could be an optimal target population for treatment with its MPC therapy.
The trial’s principal investigator and lead author of the study Emerson Perin said: "Patients with advanced chronic heart failure and severe systolic contractile dysfunction represent a major medical need despite ongoing advances in cardiovascular medicine.
"The post-hoc analysis shows that this is an appropriate target population for Mesoblast’s MPC therapy, and we hope to reproduce these findings in our ongoing Phase 3 trial."
Mesoblast’s development and commercial partner, Teva Pharmaceutical Industries, is undertaking the Phase 3 trial in 1,165 patients across several sites in North America for evaluating the use of MPC-150-IM in patients with advanced CHF.
A time-to-first-event analysis of HF-MACE is being used as the primary endpoint.
Mesoblast said the Phase 3 trial is indicated for patients with high baseline levels of NT-proBNP and a heart failure hospitalization within the last nine months, two inclusion criteria known to estimate adverse outcomes in chronic heart failure (CHF).
The company will carry out an interim analysis when 50% of the HF-MACE have occurred which will feature a test for superiority, resulting in halting the trial early depending on overwhelming efficacy.
Mesoblast’s technology platform is based on mesenchymal lineage adult stem cells (MLCs). Some of the company’s lead product candidates include MPC-150-IM for congestive heart failure and MPC-06-ID for chronic lower back pain due to moderate degenerative disc disease.
Image: Mesoblast’s Mesenchymal Precursor Cells (MPCs). Photo: courtesy of Mesoblast Ltd.