US FDA accepts Parion Sciences’ IND application for P-321 ophthalmic solution to treat dry eye disease
Parion Sciences, a company dedicated to the development of novel treatments for ocular and pulmonary diseases, has received acceptance from the US Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for P-321 ophthalmic solution for the treatment of dry eye disease. Preclinical data that supported this approval will be presented in a poster session at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO) on May 6, 2014, in Orlando, Florida.
“The FDA’s acceptance of our IND marks an important milestone in our ophthalmology programme, as we advance P-321 into a phase 1/2a clinical trial in subjects with dry eye disease,” said Paul Boucher, president, Parion Sciences. “Our programme focuses on a novel mechanism of action to restore one of the core causes of the disease, the reduced tear film volume. The potent and long lasting effect of P-321 to hydrate the ocular surface could provide a needed relief to patients suffering from dry eye. We’re excited to begin clinical studies later this year.”
The epithelial sodium channel (ENaC) plays a key role in the regulation of tear film fluid and is therefore an attractive target for the treatment of dry eye. Studies with preclinical models of dry eye disease have demonstrated that by blocking ENaC, the tear film volume is restored, maintaining its protective and lubricating actions on the ocular surface.
P-321 is the result of a comprehensive research effort to develop a potent ENaC inhibitor with unique pharmacokinetic and pharmacodynamics characteristics designed for topical ocular administration, metabolic stability and limited systemic exposure. Parion Sciences has completed all the preclinical safety and mechanistic studies required to initiate clinical studies in humans.
Parion Sciences is a development-stage company dedicated to research, development, and commercialization of treatments to restore patient’s innate mucosal surface defenses. Parion’s science driven technologies target ocular and respiratory diseases in which the patient’s ability to protect their mucosal surfaces is compromised.