Rexlemestrocel-L Shows Greatest Treatment Benefit on Major Adverse Cardiovascular Events in High-Risk Heart Failure Patients With Diabetes and/or Myocardial Ischemia

Endpoint in Line with FDA Guidance on Key Outcomes in High-Risk Patients and with Pharma Industry Drugs Approved for Cardiovascular Risk Reduction in Diabetes

Key points:

• Analysis of pre-specified high-risk groups in the DREAM-HF Phase 3 trial of rexlemestrocel-L in patients with chronic heart failure and low ejection fraction (HFrEF) showed greatest treatment benefit in major adverse cardiovascular events (MACE) of cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) in patients with diabetes and/or myocardial ischemia (72% of total treated population)  
• This target population is at very high risk for mortality and irreversible morbidity due to micro- and macro-vascular disease despite receiving optimal standard of care therapies ¹
• Rexlemestrocel-L, added to optimal standard of care therapies, reduced the 3-point MACE composite of cardiovascular death or heart attack or stroke by 37% across all HFrEF patients with diabetes and/or ischemia and by 54% in HFrEF patients with systemic inflammation (elevated baseline hs-CRP)
• United States Food & Drug Administration (FDA) has previously accepted 3-point MACE reductions of 12-14% for approval of multiple pharmaceutical industry drugs to reduce cardiovascular risk in diabetic patients ^2,3
• FDA confirmed that reduction in cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) is an acceptable clinically meaningful endpoint for determining the treatment benefit of rexlemestrocel-L for patients with HFrEF
• Mesoblast to formally submit to FDA its new analyses of outcomes in high-risk HFrEF patients with diabetes and/or myocardial ischemia to agree on a potential pathway to approval.

NEW YORK, Dec. 05, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided new analyses from the landmark DREAM-HF Phase 3 trial showing that the greatest treatment benefit from rexlemestrocel-L is in HFrEF patients with diabetes and/or ischemia, who are at high-risk of cardiovascular mortality, heart attacks or strokes.