December 23, 2009 – An investigational beta-blocker drug may be tested to see if it helps slow the progression of chronic heart failure in patients who have a specific genotype.
ARCA biopharma Inc. said this week it submitted a study protocol for review under the FDA’s special protocol assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of the drug Gencaro. The trial would include about 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro.
The drug is a beta-blocker and mild vasodilator. The FDA has previously designated the investigation of Gencaro for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population as a fast-track development program. An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval.
The proposed trial protocol includes a superiority comparison to the beta-blocker metoprolol CR/XL, which is approved for heart failure and other indications. The proposed trial protocol also includes an interim data analysis at a prespecified number of primary endpoints. If the proposed protocol and criteria are agreed to by the FDA, the company anticipates the proposed trial could reach the specified number of endpoint events as soon as two years after the trial begins. The SPA submission proposes a composite of cardiovascular mortality and cardiovascular hospitalization serve as the primary endpoint of the trial.
Subject to the timing and outcome of the FDA’s review of the SPA submission, and subject to the Company’s ability to obtain sufficient funding, the company currently expects it could begin the proposed trial in late 2010 or the first half of 2011.
For more information: www.arcabiopharma.com