Parion Sciences Announces Initiation of Phase I Clinical Trial to Evaluate Safety and Tolerability of GS9411
Receives $5 Million Milestone Payment from Gilead Sciences
DURHAM, N.C., Dec. 4 /PRNewswire/ -- Parion Sciences, Inc. today announced that its partner, Gilead Sciences (Nasdaq: GILD), has initiated a Phase I clinical trial of GS9411 in healthy volunteers to evaluate the safety and tolerability of the investigational compound. GS9411 is designed to increase airway hydration for the treatment of pulmonary disease. Previously known as P-680, GS9411 is an epithelial sodium channel (ENaC) blocker discovered by Parion, a privately held pharmaceutical company focused on treating diseases that result from the failure of the body's mucosal defenses.
The initiation of the Phase I trial triggers a $5 million milestone payment to Parion, according to an exclusive licensing and co-development agreement signed in August 2007 granting Gilead worldwide commercialization rights to GS9411 for the treatment of pulmonary diseases, including cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD) and non-CF bronchiectasis. Parion and Gilead jointly performed the IND-enabling studies for GS9411, and Gilead will assume primary development responsibilities going forward. The two companies are also collaborating on a research program to identify other promising ENaC blocker-based drug candidates utilizing Parion's proprietary ENaC-based chemistry platform.
"This is an important milestone in our program to develop ENaC inhibitors to treat a range of diseases through restoring and maintaining the hydration of mucosal surfaces," said Paul Boucher, Sr. Director, Finance and Business at Parion. "Our partnership with Gilead has enabled us to accelerate development of GS9411 and successfully meet the goals and timelines for this project. We look forward to discovering the potential of this compound to provide a new treatment option for patients suffering from cystic fibrosis, COPD and other serious lung conditions."
Epithelial sodium channel blockers, such as GS9411, are unique therapeutic agents developed to maintain and stimulate hydration on the body's mucosal surfaces, including those on the lung, mouth, nose, eye and gastrointestinal tract. Restoring the hydration of mucosal airway surfaces addresses the fundamental problem that predisposes individuals to infections in both acquired and genetic forms of chronic lung disease, including COPD and CF.
About Parion Sciences
Based in Durham, NC, Parion Sciences is a privately-held, development-stage pharmaceutical company that is leveraging its proprietary small molecule chemistry and epithelial biology expertise to discover and develop an innovative pipeline of therapies for diseases resulting from the failure of the body's mucosal defenses, including chronic obstructive pulmonary disorder (COPD), cystic fibrosis, bronchiactesis and Sjogren's syndrome. Parion's lead product candidate, P-552, is currently in Phase II clinical development for the treatment dry mouth associated with Sjogren's syndrome. Parion was founded based on technology from University of North Carolina, Chapel Hill (UNC-CH) and has received grant funding from the National Institutes of Health (NIH) and Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) For more information, please visit www.parion.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
For information about the Cystic Fibrosis Foundation, please visit www.cff.org .