Mesoblast (ASX:MSB) announced that additional Phase 2 trial results of its lead product candidate for the treatment of chronic heart failure (CHF) were presented at the 19th Annual Scientific Meeting of the Heart Failure Society of America in the US.
According to the company, the results showed that its mesenchymal precursor cell (MPC) therapy had the greatest cardioprotective effect in the subset of patients with more advanced heart failure.
It said a post-hoc analysis was performed in 30 patients from the Phase 2 trial who had been randomised to receive either placebo or a single administration of 150 million MPCs (MPC-150-IM).
"The results suggest that patients with advanced heart failure may be an optimal target population for treatment with Mesoblast’s MPC therapy," it said.
The objective of the analysis was to evaluate the efficacy of MPC-150-IM in patients with advanced heart failure, as defined by substantial baseline left ventricular (LV) contractile abnormality (LV end systolic volume, LVESV, >100 ml).
LVESV >100 ml is more than three standard deviations above normal LVESV and is a predictor of poor long-term outcomes in patients with CHF. A further sensitivity analysis across every decile in baseline LVESV between 70 ml and 120 ml confirmed the findings seen in the stratification using a LVESV >100 ml.
A key conclusion of the analysis is that, in CHF patients with LV systolic dysfunction, a single administration of 150 million MPCs resulted in a significant cardio-protective effect and prevention of any HF-MACE over 36 months of follow up.
"Patients with baseline LVESV >100 ml may be an optimal target group for the potential cardio-protective benefits of MPC therapy," said the company.
Mesoblast said an ongoing Phase 3 trial, using a time-to-first-event analysis of HF-MACE as the primary endpoint, is being conducted in 1,165 patients by its development and commercial partner, Teva Pharmaceutical Industries, across multiple sites in North America to investigate the use of MPC-150-IM in patients with advanced CHF.
According to the company, following recent discussions with the US FDA, an interim analysis will be performed when 50 per cent of the time-to-first heart failure-related major adverse cardiovascular events have occurred, which will include a test for superiority allowing for the possibility of stopping of the trial early based on overwhelming efficacy.