Corthera Inc. has announced that results from Pre-RELAX-AHF, the Phase II portion of a Phase II/III multicenter, randomized, double-blind, placebo-controlled international study, demonstrated promising efficacy and safety for relaxin, the company's investigational drug for treatment of acute heart failure (AHF).
The report containing the detailed study results is being published on-line in the medical journal, The Lancet.
The data from 234 patients in eight countries showed that when administered with standard-of-care therapy for acute heart failure, relaxin caused rapid, substantial and sustained relief from dyspnea (breathlessness). Relaxin also demonstrated consistent trends in improvement of the hospital course of patients, prevention of heart failure worsening during hospitalization, shortening of in hospital stay and improved longer-term outcomes following discharge when compared to placebo. John R. Teerlink, M.D., professor of medicine, University of California San Francisco, Director of Heart Failure, Veterans Affairs Medical Center, San Francisco and co-principal investigator of the study, presented the findings today at a late-breaking clinical trials session at the American College of Cardiology's (ACC) 58th Annual Scientific Session in Orlando, Fla.
"The results of the study clearly indicated favorable treatment effects on symptoms, signs and outcomes in patients hospitalized with AHF," said Teerlink. "The use of relaxin led to considerable improvement in dyspnea when compared to placebo and lasted up to 14 days, longer than any therapy studied. In this study, relaxin administration was safe and well tolerated. These results provide a clear direction for the Phase III study."
Marco Metra, M.D., professor of cardiology at the University of Brescia, Italy, and co-principal investigator of the study, added: "There has been an epidemic of hospitalization for heart failure and there is a great need for an advance in the treatment of AHF. The potential benefits of relaxin shown by the Phase II study are extremely encouraging, and the larger Phase III study currently getting underway, RELAX-AHF-1, will aim to confirm relaxin's safety and efficacy in treating patients with AHF."
"We are very pleased to have our study results presented in this important forum at the ACC and published in the prestigious journal The Lancet. This represents international recognition of the important need for new therapies for AHF and the promise that relaxin holds for patients with AHF," added Stan Abel, CEO of Corthera.
Corthera's Pre-RELAX-AHF / RELAX-AHF study is a Phase II/III, multicenter, randomized, double-blind, placebo-controlled, parallel-group, international trial designed to evaluate the efficacy and safety of relaxin for the treatment of AHF. In the Phase II Pre-RELAX-AHF study, the objective was proof-of-concept and dose and endpoint selection. Patients selected for the study presented to the hospital with dyspnea due to AHF and with normal or elevated blood pressure. In the Phase III RELAX-AHF study, the objective is to confirm safety and efficacy. The Pre-RELAX-AHF / RELAX-AHF study was designed and conducted in collaboration with Momentum Research, headed by Dr. Gad Cotter, a noted heart failure expert.