San Francisco, January 31st, 2018 – Recardio Inc. today announced that it has received the FDA approval for its Phase 2 study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction.
Following successful completion of a Phase 1 study with parenterally administered dutogliptin, Recardio is preparing to initiate a Phase 2 study. “We have selected the dutogliptin dosage and regimen for our Phase 2 combination study with filgrastim based on the safety, pharmacokinetic and pharmacodynamic data results from our recently completed Phase 1 study in healthy volunteers.” said Darrell Nix, Chief Scientific Officer of Recardio.
After receiving FDA approval for this global, randomized, double-blind, placebo-controlled, safety and efficacy Phase 2 Study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction, the study is being submitted in various European countries and Recardio will be starting patient enrolment subject to the various approvals in Q2 2018.
“Receiving favorable review of the protocol from the FDA for this Phase 2 study represents an important milestone in our efforts to bring this important treatment to patients with acute myocardial infarction.” said Roman Schenk, Executive Chairman of Recardio. “This Phase 2 study is also an important step for our development of a therapeutic platform with dutogliptin 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 pursuing a Phase 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/