Durham, NC, April 5, 2023 Parion Sciences (Parion) today announced receipt of a positive opinion from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) for the Paediatric Investigation Plan (PIP) for Idrevloride Inhalation Solution, an epithelial sodium channel (ENaC) inhibitor, currently in development for the treatment of primary ciliary dyskinesia (PCD).
Parion Sciences P‐1037 Inhalation Solution receives Orphan Drug Designation from the EMA for the Treatment of Primary Ciliary Dyskinesia
Company Release November 17, 2020
Durham, NC. Parion Sciences, Inc. (Parion), a clinical-stage pharmaceutical company focused on treatments of unmet respiratory diseases, announced today, that on November 16, 2020, the European Commission has adopted the designation of P-1037 Inhalation Solution (P-1037 IS), a novel, epithelial sodium channel (ENaC) inhibitor, under evaluation as a potential treatment of primary ciliary dyskinesia (PCD), as an Orphan Drug. PCD is a serious disease that affects approximately 1 in 15,000 people worldwide.
FDA Grants Orphan Drug Designation, Fast Track Designation and Rare Pediatric Disease Designation to Parion Sciences P-1037 Inhalation Solution for the Treatment of Primary Ciliary Dyskinesia
Company Release July 29, 2020
Durham, NC. Parion Sciences, Inc. (“Parion”), a clinical-stage pharmaceutical company focused on treatments of unmet respiratory diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation, Fast Track Designation and Rare Pediatric Disease Designation to P-1037 Inhalation Solution (P-1037 IS). P-1037 IS, a novel, epithelial sodium channel (ENaC) inhibitor in a nebulized solution is being evaluated for the potential treatment of Primary Ciliary Dyskinesia (“PCD”).
Parion Sciences Reacquires Rights to Epithelial Sodium Channel Inhibitors
Durham, NC (January 23, 2020) – Parion Sciences, a company dedicated to the development of novel treatments for pulmonary diseases, announced today that it has reached an agreement with Vertex Pharmaceuticals, Inc. to reacquire the pulmonary rights to epithelial sodium channel (ENaC) inhibitors developed under a collaboration announced between the parties in 2015. Under this agreement, Vertex is eligible to receive future undisclosed royalties based upon commercial success.
Parion Sciences and Takeda End Collaboration on P-321 for Ophthalmic Indications
Durham, North Carolina – October 31, 2019 – Parion Sciences, Inc. today announced the termination of the License Agreement dated April 28, 2017 between Parion and Shire (now Takeda Pharmaceutical Company Limited) that granted Shire exclusive worldwide rights to develop and commercialize P-321. As a result of the termination, Parion regains exclusive development and commercial rights to P-321 for all indications.
Shire and Parion Sciences Enter into a Collaborative License Agreement to Advance P-321 for Ophthalmic Indications
Demonstrates ongoing commitment to innovation in ophthalmics for Shire
P-321 is a Phase 2 investigational topical treatment for dry eye disease
Lexington, Massachusetts, and Durham, North Carolina, US – May 1, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG) and Parion Sciences, Inc. today announced they have entered into an agreement granting Shire exclusive worldwide rights to develop and commercialize P-321. Shire will lead development of P-321, an investigational epithelial sodium channel (ENaC) inhibitor for the potential treatment of dry eye disease in adults, with the opportunity for Parion to co-fund.
Topical ENaC blocker serves as novel approach to tear film
First-in-human trial encouraging, identifies agent that is associated with signs of improvement in tear function
Parion Sciences Announces Presentation of Clinical Data with Novel Pulmonary Delivery Device at the 2016 North American Cystic Fibrosis Conference
Clinical Data to be presented for a novel device for transnasal delivery of a pulmonary aerosol in children with Cystic Fibrosis
Durham, NC (October 25, 2016) – Parion Sciences, a company dedicated to the development of novel treatments for pulmonary and ocular diseases, announced that an abstract from its pulmonary research and development efforts will be presented at the 30th Annual North American Cystic Fibrosis Conference (NACFC) in Orlando, Florida, October 27 through 29, 2016.
Parion Sciences Announces Initiation of Phase 2 Clinical Trial of P-321 for the Treatment of Dry Eye Disease
First Patient Enrolled in P-321-202 Clinical Trial
Durham, NC (July 26, 2016) – Parion Sciences, a company dedicated to the development of novel treatments for pulmonary and ocular diseases, announced today it has initiated a phase 2 clinical trial of P-321 Ophthalmic Solution in patients with Dry Eye Disease (DED). P-321 is a potent inhibitor of the epithelial sodium channels (ENaC) on the ocular surface, and is expected to restore the tear film on the ocular surface in those patients with dry eye disease. Earlier this year the results of a Phase 1/2a safety, tolerability, and pharmacokinetics study in subjects with dry eye were presented.
Parion Sciences Announces the Presentation of Clinical Data on P-321 Ophthalmic Solution for the treatment of Dry Eye Disease at the Association for Research in Vision and Ophthalmology (ARVO 2016)
Data on P-321 from clinical research to be presented on May 3rd
Durham, NC (May 2, 2016) – Parion Sciences, a company dedicated to the development of novel treatments for pulmonary and epithelial diseases, announced today the presentation of a poster containing clinical data for the development stage dry eye treatment P-321. The presentation is a review of the results from a clinical trial of P-321 versus placebo in patients with dry eye disease and will be presented at the Association for Research in Vision and Ophthalmology (ARVO) in Seattle, Washington on May 3rd, 2016.