ARCA biopharma, Inc. (Nasdaq: ABIO) today announced that it has received notification of a grant of $489,000 under the Qualifying Therapeutic Discovery Project.
The Qualifying Therapeutic Discovery Project Credit is provided under section 48D of the Internal Revenue Code (IRC), as added to the IRC by the Patient Protection and Affordable Care Act of 2010 (P.L. 111-148).
“We are very pleased to receive grants under this program to support our further development of new cardiovascular therapeutics,” said Michael R. Bristow, President and Chief Executive Officer of ARCA. “Our current lead development program plan includes the first full-sized cardiovascular trial performed in a genetically defined population designed to increase the efficacy of the drug according to a patient’s genetic makeup. We believe this personalized medicine approach to drug candidate development offers the possibility of improved health outcomes for patients and more cost-effective healthcare.”
(bucindolol hydrochloride) is a pharmacologically unique beta-blocker and mild vasodilator being developed for the treatment of chronic heart failure (HF). Gencaro is an oral tablet formulation, dosed twice daily. Gencaro is considered part of the beta-blocker class because of its property of blocking beta-1 as well as beta-2 receptors in the heart, preventing these receptors from binding with other molecules that would otherwise activate the receptor. Because of its mild vasodilator effects, the Company believes Gencaro is well-tolerated in patients with advanced HF.
On May 17, 2010, ARCA announced that it reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a clinical trial to assess the safety and efficacy of bucindolol in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to bucindolol. 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 FDA has previously designated as a Fast Track development program the investigation of Gencaro for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. ARCA has been awarded a patent from the U.S. Patent and Trademark Office (March 2010) and a patent from the European Patent Office (October 2010) on methods of treating heart failure patients with bucindolol based on genetic testing.