Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics, announced today that its Phase 2, INSPIRE study evaluating a single-dose intravenous infusion of CAP-1002 as a potential treatment option for hospitalized patients with advanced symptoms of COVID-19 met its primary objective of safety. All efficacy endpoints were exploratory as the study was not powered to detect treatment differences. In the study of 63 randomized patients, 31% were admitted to the ICU prior to initiation of treatment. The WHO ordinal scale indicated severe disease in 82% of patients (range: 0-8, median 5).
Study Findings
Safety: The results from the INSPIRE trial suggest that CAP-1002 was safe, well tolerated and consistent with the historically observed safety profile of this therapy.
Exploratory Efficacy: Overall mortality in the study was 20%, with 6 deaths in the placebo group and 5 deaths in the CAP-1002 group. (n=11; p=NS)
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