BROOMFIELD, Colo.--(BUSINESS WIRE)--
ARCA biopharma, Inc. (ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today provided a general business update and clinical development guidance.
ARCA was founded on the belief that a personalized medicine approach to drug development, tailoring medical treatment to the individual genetic characteristics of each patient, can enable more effective therapies, improve patient outcomes and reduce healthcare costs. ARCAs lead development program is intended to be a direct implementation of those ideas. Gencaro (bucindolol hydrochloride) is being developed as a potential treatment for atrial fibrillation (AF). ARCA has identified common genetic variations that it believes may predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted AF prevention treatment. AF is considered an epidemic cardiovascular disease with an estimated prevalence of at least 2.7 million Americans in 2010.
We believe we have a significant opportunity to improve the treatment options for patients living with atrial fibrillation, said Dr. Michael R. Bristow, President and Chief Executive Officer of ARCA. With the completion of our recent capital raise, and the support of Medtronic, we now have the resources to advance Gencaro into Phase 2B clinical evaluation. We believe there is an unmet medical need for new atrial fibrillation treatments that have fewer side effects than currently available therapies.
In June, the Company completed an equity offering, raising net proceeds of approximately $18 million. As of June 30, 2013, the Company had approximately $20.4 million in cash and cash equivalents.
ARCA and Medtronic, Inc. (MDT), a leader in medical technologies to improve the treatment of chronic diseases, including cardiac rhythm disorders, have entered into a collaboration agreement for the Phase 2B portion of GENETIC-AF, the Companys Phase 2B/3 trial evaluating Gencaroas a potential treatment for AF.
GENETIC-AF Clinical Trial
GENETIC-AF is planned as a Phase 2B/3, multi-center, randomized, double-blind clinical trial comparing Gencaro to metoprolol CR/XL for prevention of AF in patients with heart failure and reduced left ventricular ejection fraction (HFREF). ARCA plans to enroll only patients with the genetic variant of the beta-1 cardiac receptor which the Company believes responds most favorably to Gencaro. GENETIC-AF has an adaptive design, under which the Company plans to initiate it as a Phase 2B study in approximately 200 patients and then, depending on the results of an interim analysis by the trial Data Safety Monitoring Board (DSMB), expand the trial to a Phase 3 study by enrolling an estimated additional 420 patients. The Company now anticipates that patient enrollment in GENETIC-AF will begin in the first quarter of 2014.
Under the collaboration with Medtronic, ARCA plans to conduct a substudy that will include continuous monitoring of the cardiac rhythms of all 200 patients enrolled during the Phase 2B portion of GENETIC-AF. Each patient will have heart rhythm monitoring via a Medtronic device, either a previously implanted cardiac resynchronization or defibrillation device, or a previously or newly inserted Reveal loop recorder. The collaboration substudy will measure AF burden, defined as a patients actual time in AF regardless of symptoms. For the DSMB interim analysis, AF burden and the primary endpoint of the study, time to recurrence of symptomatic AF after electrical cardioversion, or death, will be reviewed by the DSMB to determine if there is sufficient potential for a statistically significant efficacy signal to be determined for all patients enrolled in the Phase 2B/3 study.
Upcoming GENETIC-AF Trial Implementation Milestones
Read the original post:
ARCA biopharma Provides Business Update