San Francisco, March 27th, 2017 – Recardio Inc. Receives FDA Clearance of IND in Regenerative Therapy Program.
Recardio Inc. today announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application to initiate clinical development of Dutogliptin for acute myocardial infarction, the first target in the company’s regenerative therapy program.
The IND filing for Dutogliptin was supported by strong preclinical data that was also presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference 2016 on October 29 in Washington. Recardio will now move this therapy quickly into an efficient Phase 1 study, followed by a global Phase 2 study.
“The Phase 1 single and multiple ascending dose clinical study with Dutogliptin will confirm the drug’s safety, pharmacokinetic and pharmacodynamic parameters and inform the dose selection for Phase 2.” said Darrell Nix, Chief Scientific Officer of Recardio. The study will enroll up to 45 healthy humans at a single site.
“Opening the US IND for our regenerative therapy with Dutogliptin is an important milestone to bring this important treatment to patients with acute myocardial infarction.” said Roman Schenk, Executive Chairman of Recardio. “This is the first step to fully develop the therapeutic platform as a regenerative medication for patients with a range of cardiovascular diseases.”
More information about the clinical program is available by visiting the following link.
Recardio Inc. is a clinical-stage life science company focusing on regenerative therapies for cardiovascular diseases. The company’s lead drug candidate, Dutogliptin, is a DPP-IV inhibitor that has demonstrated significant effects in activating SDF-1, a protein that is critical for cardiac regeneration. The company is initiating a Phase 1/2 clinical program, seeking to fully develop the therapeutic platform as a regenerative medication for patients with various cardiovascular diseases including acute myocardial infarction and chronic heart failure, with the potential of improving heart function, quality of life and survival. For more information, visit: http://www.recardio.eu/