Cordex Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the design of pivotal, Phase 2b/3 clinical trials evaluating its lead product ATPace™ as an antiarrhythmic drug for the acute treatment of patients with paroxysmal supraventricular tachycardia (PSVT) under the Special Protocol Assessment (SPA) process.

ATPace™ is a novel stable liquid formulation of adenosine 5’-triphosphate (ATP). It is being developed as a therapeutic and diagnostic drug for the management of patients with cardiac arrhythmias. ATP has been used in Europe for more than five decades as the drug of choice for the acute termination of PSVT. During this extended period of time, formulations of ATP have manifested an excellent safety and efficacy profile.

Cordex intends to initiate prospective, double-blind, placebo-controlled and randomized clinical trials with its lead product ATPace™ in approximately 200 patients aimed at demonstrating clinical safety and efficacy sufficient to support a New Drug Application filing of ATPace™ for the treatment of PSVT in emergency room patients.

“We are very pleased with the FDA’s decision; we believe that data to be obtained in the proposed trials would constitute sufficient evidence to support the marketing approval of ATPace™ for the proposed indication,” commented Amir Pelleg, PhD, Cordex’s President and CSO. “Due to its unique mechanism of action in the heart, which involves a central vagal reflex and adenosine, the product of its rapid degradation, ATPace™ has the potential to be an important advance in the treatment of patients with PSVT,” he added.