Parion has a plan for the first clinical trial in patients with dry eye disease to initiate in July 2014
Durham, NC (June 12, 2014) – Parion Sciences, Inc. (Parion) announced today that Parion and Santen Pharmaceutical Co., Ltd. (Santen) have entered into the “OPTION, LICENSE AND DEVELOPMENT AGREEMENT”, an exclusive option agreement for the development and commercialization of P-321 for dry eye disease in certain Asian territories. On May 1, 2014 Parion announced FDA Acceptance of the Investigational New Drug Application for clinical testing of P-321 Ophthalmic Solution for the Treatment of Dry Eye Disease. Parion plans to initiate a Phase 1/2a clinical trial in patients suffering from dry eye disease in July, 2014 in the United States.
Under the terms of agreement, Santen will make an undisclosed option payment to secure certain rights to P-321 and to support the upcoming Phase 1/2a clinical trial. Should Santen elect to exercise their option, Santen will have responsibility for all clinical, regulatory, and commercial activity for the ophthalmic use of P-321 in the agreed Asian territories. Parion retains all rights to develop and commercialize P-321 in the rest of the world, including North America and Europe.
“Parion is excited to be partnering with Santen, a global leader in Ophthalmology, who has a proven track record in commercializing multiple dry eye products in Asia.” said Paul Boucher, President of Parion Sciences. “P-321’s unique mechanism of action aims to restore the eye’s tear film volume, which is expected to bring relief for those patients with dry eye. The combined expertise of the Parion and Santen teams will greatly benefit the P-321 program and our collaborative Phase 1/2A study.”
About ENaC and P-321
The epithelial sodium channel (ENaC) plays a key role in the regulation of tear film volume 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 product of a comprehensive research effort to develop a potent ENaC inhibitor with unique pharmacokinetic and pharmacodynamic 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 in the US. Parion’s dry eye program was supported by the NIH through the National Eye Institute and the National Center for Advancing Translational Sciences (NCATS) BrIDGs program.
Founded in 1890, Santen is a global company headquartered in Osaka, Japan. Santen researches, develops and markets ophthalmic products for physicians worldwide. Among prescription ophthalmic pharmaceuticals, Santen holds the top share within the Japanese market and is one of the leading ophthalmic companies worldwide. Tokyo Stock Exchange code 4536. For more information, visit www.santen.com.
About Parion Sciences
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.
Parion Sciences was founded based on proprietary ENaC inhibitor technology from The University of North Carolina, Chapel Hill and has received grant funding from the National Institutes of Health and the Cystic Fibrosis Foundation Therapeutics, Inc. Today, while Parion remains at the forefront of ENaC research, the company is leveraging its research and development expertise in epithelial biology to expand into new indications and platforms that further treat additional mucosal defects. Parion is currently advancing several programs through clinical development including the tPAD platform, P-1037 for pulmonary diseases and P-321 for the treatment of dry eye disease.
Parion Sciences, Inc.