The Mesoblast Limited (ASX: MSB) share price is going nuts again today after giving an update.
Mesoblast describes itself as a global leader in allogeneic cellular medicines for inflammatory diseases.
What happened?
Mesoblast announced additional results from its DREAM-HF randomized controlled Phase 3 trial in 537 treated patients with chronic heart failure with reduced left ventricular ejection fraction (HFrEF) who received rexlemestrocel-L or control sham.
A single dose of rexlemestrocel-L resulted in substantial and durable reductions in heart attacks, strokes and cardiac deaths, according to the company.
Mesoblast said that since existing therapies have only minimal or no benefit on these endpoints, these notable outcomes may signal a breakthrough in addressing the principal unmet needs in patients with chronic heart failure.
The results of this trial identified New York Heart Association class II HFrEF patients as the optimal target population for the greatest rexlemestrocel-L treatment effect, and therefore will be the focus for registration and commercialisation of rexlemestrocel-L in the largest market in heart failure.
Mesoblast revealed that the incidence of heart attacks and strokes were reduced by 60% over a median follow-up period of 30 months after a single dose of rexlemestrocel-L in the 537 patients. Patients who received rexlemestrocel-L had a 68% reduction in the rate of recurrent hospitalisations from non-fatal heart attacks or strokes compared with controls.
The incidence of death of cardiovascular causes was reduced by 60% following a single dose of rexlemestrocel-L in the 206 patients with NYHA class II disease.
The combination of the three pre-specified outcomes of cardiac death, heart attack or strike into a single composite outcome – called the three point ‘Major Adverse Cardiovascular Event’ (MACE) is an endpoint used by the US FDA to determine cardiovascular risk. Rexlemestrocel-L reduced this three-point MACE by 30% compared to controls across the population of 537 patients.
Summary thoughts
Mesoblast said that based on the observed reduction in mortality and morbidity in the phase 3 trial, Mesoblast intends to meet with the FDA to discuss a potential approval pathway.
I can see why the Mesoblast share price has jumped in response to this news. There may be potential for the company to bounce back further, but I don’t like investing in businesses that are so volatile and are based on a binary outcome where things either look very good or bad.
In the healthcare space there are other ASX growth shares I’d rather buy such as Volpara Health Technologies Ltd (ASX: VHT) and Pro Medicus Limited (ASX: PME).
