ATRIAL FIBRILLATION (AF)
Atrial fibrillation is a disorder in which the normally regular and coordinated contraction pattern of the heart's two small upper chambers (the atria) becomes irregular and uncoordinated. The irregular contraction pattern associated with AF causes blood to pool in the atria, predisposing the formation of clots. These clots may travel from the heart and become lodged in the arteries leading to the brain and other organs, thereby blocking necessary blood flow and potentially resulting in stroke. Studies estimate AF affected between 2.4 million and 3.0 million Americans in 2005. Those same studies estimate that the prevalence of AF will increase to between 3.8 million and 4.8 million by 2025.
AF CLINICAL TRIAL
We are planning to initiate a Phase 3 clinical study of Gencaro in AF patients with HFREF, known as GENETIC AF. We believe AF-HFREF is an attractive indication for Gencaro because data from BEST, the previously conducted Phase 3 HF trial involving Gencaro in 2,708 HF patients, suggest Gencaro may have a potentially significant effect in reducing and/or preventing AF. Based on the BEST trial we believe Gencaro's prevention of AF in HF patients is pharmacogenetically regulated, similar to the effects on HF clinical endpoints. The initial phase of GENETIC-AF is planned as a 200 patient, Phase 2B study comparing Gencaro to metoprolol CR/XL for prevention of recurrent AF post electrical cardioversion, in patients with heart failure or left ventricular dysfunction. The results from first 200 patients would be used in an adaptive design to determine if the trial goes to Phase 3 and full enrollment of 620 patients. We believe that this adaptive feature of GENETIC-AF is consistent with current FDA guidance on optimal clinical trial design. ARCA is in discussions with potential academic and industry partners to secure funding for GENETIC-AF. We anticipate that the trial could begin approximately 6 months after we obtain sufficient funding.