Cordex Pharma, Inc has filed a formulation patent covering its lead product, ATPace. It is a stable liquid formulation of adenosine triposphate (ATP) for intravenous administration. ATPace is being developed as a therapeutic drug for the acute management of paroxysmal supraventricular tachycardia (PSVT) as well as a diagnostic test for the identification of patients with bradycardic (slow heart rate) syncope who may benefit from pacemaker therapy.
Injectable formulations of ATP, similar to ATPace, have been approved and marketed in Europe for over 50 years as safe and efficacious pharmaceutical treatments for PSVT.
Cordex had recently announced the submission to the FDA of an amended phase-3 clinical trial protocol with ATPace as an antiarrhythmic drug for the conversion of PSVT to normal sinus rhythm. The FDA is currently reviewing this protocol through the Special Protocol Assessment procedure.
A stable liquid formulation of ATP is a prerequisite for ATPace's marketing and clinical superiority over adenosine, the only approved competition in the US. The maintenance of intact ATP molecules in the solution is critical for the unique bradycardic effects of ATP, in particular its blockade of atrio-ventricular (AV) nodal conduction. Specifically, ATP is believed to have dual inhibitory action, one mediated by adenosine, the product of its rapid degradation in the blood vasculature by ecto-enzymes, and the other a rapid and potent ATP-triggered vagal reflex. The latter mechanism of action is believed to be responsible for its superior efficacy over adenosine, which does not trigger a vagal reflex in the heart. Physical vagal maneuvers aimed at enhancing vagal input to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia in certain cases.
"We are very pleased with the unmatched stability of our proprietary formulation, which is over four years. It ensures a reliable product that maintains its pharmacologic profile throughout its shelf life," commented Amir Pelleg, Cordex's president and CSO. "This patent application will add additional coverage to that afforded by existing patents and other pending patent applications," he added.
PSVT is an episodic, rapid, regular heart rate originating in the atria. The heart rate in PSVT can range from 150 to 250 beats per minute.
Cordex is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging pharmacology of adenosine triphosphate (ATP) and nitric oxide (NO).