ARCA Announces Special Protocol Assessment Agreement With FDA For Bucindolol Development In Genotype-Defined Heart Failure Population
The trial protocol includes a superiority comparison of bucindolol to the beta-blocker metoprolol CR/XL, which is approved for heart failure and other indications and which has not been shown to exhibit any differentiation of clinical effects in heart failure patients with the beta-1 389 Arg/Arg genotype as compared to the Gly genotypes. The primary endpoint of the planned trial is a composite of cardiovascular mortality and cardiovascular hospitalization. The trial protocol includes two interim data analyses at pre-specified numbers of primary endpoints. If the results of either of the interim analyses meet the pre-specified criteria, ARCA would be able to formally submit a complete response to the FDA’s May 2009 Complete Response Letter and the results of the interim analysis could serve as the clinical effectiveness basis for FDA approval. The first interim data analysis is planned at 630 primary endpoints (57% of the projected total number). The trial protocol estimates reaching the first interim analysis 24-30 months into the trial. The SPA-defined criteria for fulfilling the FDA’s request for additional evidence of effectiveness include a hazard ratio 95% confidence interval upper bound of <0.999 (a p-value of approximately 0.050) and safety comparable to metoprolol CR/XL. Even with a positive outcome at either of the interim analyses, the planned trial is designed to proceed to conclusion, estimated to take a total of 3.5 years (including the time to reach the interim analysis). In order to not influence the planned trial’s subsequent completion, if the results of an interim data analysis are adequate to support potential approval of bucindolol, ARCA’s goal would be to have bucindolol commercially available no sooner than immediately after the conclusion of the trial.
With a clear regulatory and clinical pathway now identified, the Company is continuing to evaluate several options for funding the proposed clinical trial. These options primarily include a strategic partnership, license and/or government funding. In the first quarter of the year, the Company raised approximately $6.8 million, net of offering costs, to provide additional time to effectively pursue these options. As the Company evaluates these options, its primary goal is to identify the most capital efficient path to create stockholder value. Subject to the Company’s ability to obtain sufficient funding, the Company currently expects it could begin the proposed trial in the second half of 2011.
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