Capricor Therapeutics has reported topline data from the Phase II INSPIRE trial of its single-dose cell therapy, CAP-1002, to potentially treat hospitalised patients with severe Covid-19.
CAP-1002 comprises allogeneic cardiosphere-derived cells (CDCs), a kind of progenitor cell.
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The double-blind, randomised, placebo-controlled trial enrolled 63 severe to critical Covid-19 patients who needed supplemental oxygen.
They were randomised into a 1:1 ratio to receive either CAP-1002 or placebo and underwent baseline safety and efficacy analyses until 90 days after infusion.
Carried out at various sites in the US, the trial assessed the safety of a single intravenous dose of CAP-1002 and various exploratory efficacy outcomes as the primary objective.
Capricor noted that the efficacy endpoints of the trial were exploratory as it was not intended to identify treatment differences.
According to the findings, the trial of CAP-1002 in hospitalised Covid-19 patients met the primary objective of safety.
In the trial, CAP-1002 was demonstrated to be safe, well-tolerated and in line with its previously reported safety profile.
Overall mortality was found to be 20%, with six and five deaths reported in the placebo arm and CAP-1002 arm, respectively.
Capricor CEO Linda Marbán said: “We were pleased that CAP-1002 was shown to be safe and well-tolerated in this group of patients that were profoundly ill with symptoms of Covid-19, which bodes well for the general safety and tolerability of infused CAP-1002 even in this heterogeneous and severely sick population of patients.
“In light of the effectiveness and widespread use of available vaccines, the reduction in mortality and the decline in Covid-19 hospitalisation rates in the United States, we will continue to evaluate the next steps for this programme.”
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