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Capricor Therapeutics Reports Topline Results from Phase 2 Exploratory INSPIRE Trial in Severe Hospitalized COVID-19 Patients
-Primary Objective of Study Met: CAP-1002 was Safe and Well Tolerated- SAN DIEGO, March 28, 2022 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a
About this update from Capricor Therapeutics, Inc.
[{"type":"text","content":"-Primary Objective of Study Met: CAP-1002 was Safe and Well Tolerated- SAN DIEGO, March 28, 2022 (GLOBE NEWSWIRE) -- 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) “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,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “In light of the effectiveness and widespread use of available vaccines, the reduction in mortality and the decline in COVID-19 hospitalization rates in the United States, we will continue to evaluate the next steps for this program. Further, as we continue to analyze this dataset in more detail, we will remain open to discussing potential partnering opportunities should they become available.” About INSPIRE The INSPIRE trial is a Phase 2, randomized, double-blind, placebo-controlled study that enrolled patients with a clinical diagnosis of COVID-19 confirmed by laboratory testing and are in severe to critical condition requiring supplemental oxygen. The study was conducted at multiple sites in the United States and randomized 63 patients. The primary objective of the study was to evaluate the safety of a single-dose of intravenously infused CAP-1002 as well as evaluate multiple ...