Recardio's Positive Phase 2 Results Presented as Latebreaker at World Congress on Acute Heart Failure 2022 in Madrid
Recardio Inc., a clinical-stage life science company developing regenerative therapies for cardiovascular diseases, announced that the positive study results of Recardio's Phase 2 clinical study in Acute Myocardial Infarction were presented on Saturday, May 21, 2022, during the Latebreaker Session at the World Congress on Acute Heart Failure 2022 in Madrid.
SAN FRANCISCO, May 23, 2022 (GLOBE NEWSWIRE) -- Entitled "Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptinin Combination with Filgrastim in Early Recovery" the study results were presented during the Latebreaker Session on Saturday, May 21, 2022 at the World Congress on Acute Heart Failure 2022 in Madrid by the Principal Investigator Dirk von Lewinski from the Department of Cardiology of the Medical University of Graz, Austria.
Patients included in this trial experienced a severe form of Myocardial Infarction known as STEMI. Soon after the initial intervention to re-establish adequate blood flow to the coronary arteries, patients began a two-week treatment with Recardio's dutogliptin, a small molecule that enables sustained homing of mobilised stem cells to the site of cardiac injury. By releasing paracrine factors, stem cells have been shown to have significant repair and regenerative effects that improve healing and recovery of cardiac function after the infarction. Twelve European centers participated in this study, which had to be closed out early due to the SARS-CoV2 pandemic, with 47 subjects (planned 110) randomized (25 treatment group and 22 placebo) and evaluable.
The results demonstrated that the use of dutogliptin in co-administration with filgrastim was safe. None of the subjects experienced non-fatal stroke, stent thrombosis or cardiovascular death, and there was no statistically significant difference between the groups with respect to serious or severe treatment-emergent adverse events (TEAE). More patients in the active group had positive changes in left ventricular parameters over time compared to the placebo group. Improvement in cardiac tissue health over time were noted in more subjects in the treatment group than in the placebo group. FWHM LGE and relative FWHM LGE mass declined more markedly indicating a trend towards smaller remaining infarct areas in the treatment group. In addition, the positive trend of better RV function in the active group suggests a stronger effect in larger MIs, which is of prognostic value for DCM.
Considering the morbidity and quality of life years lost post-STEMI as well as the excellent safety profile of dutogliptin along with data suggesting potential positive effects on cardiac function, a study of this therapeutic approach in a large, adequately powered NDA-enabling study is warranted. These data were already submitted together with the proposed study design and sample size of the pivotal outcome trial to the agencies.
Recardio Inc. is a late clinical-stage life science company focusing on therapies for cardiovascular and other diseases. The company is located in San Francisco, California, and is having its operations in the USA and Europe. The company's lead drug candidate, dutogliptin, is a DPP-IV inhibitor having demonstrated significant effects in activating various chemokines like SDF-1, a protein that is critical for cardiac regeneration resulting in healing cardia tissue after an injury.
Recardio is currently initiating its global pivotal Phase 3 clinical program in acute myocardial infarction for market authorization in major markets and will fully develop the therapeutic platform as a regenerative medication for patients with various cardiovascular diseases.
In addition, other development programs are in preclinical stage.
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