For Immediate Release
Contact: Paul Boucher
Parion Sciences
919-313-1195
pboucher@parion.com
PARION SCIENCES ANNOUNCES PHASE I CLINICAL RESULTS
FOR NOVEL DRY MOUTH TREATMENT
Results Reported at American Association for Dental Research Meeting
DALLAS, TX – April 7, 2008 – Parion Sciences, Inc., a privately-held, development-stage pharmaceutical company dedicated to treating diseases resulting from the failure of the body’s mucosal defenses, today announced preliminary results from a Phase I clinical safety study of a novel sodium channel blocker, P-552-02, as a topical therapy for dry mouth associated with primary Sjogren’s syndrome. The preliminary results of the study showed that P-552-02 was safe and well tolerated, both locally in the oral cavity and systemically. No side effects or other safety issues were reported in the study. The results were reported on April 4 by Athena Papas, DMD, Ph.D., Professor at Tufts University School of Dental Medicine at the Annual Meeting of the American Association for Dental Research.
The trial was a 28-day, 30-patient, randomized, double-blind, placebo-controlled, crossover study designed to assess the effect of a six-time daily oral rinse formulation of P-552-02 versus placebo on oral and systemic safety parameters and the symptoms of dry mouth. The primary efficacy endpoint, a global improvement in the “feeling of dry mouth” as determined by a single retrospective “recall” report at day 28, was not met. However, an assessment of "global change in dry mouth" as determined by the change in visual analog scale (VAS) measurements 12 hours after dosing at day 7 and day 28 revealed significant improvement in the global dry mouth scores. VAS scores that measured the change at day 28 in mouth dryness, tongue dryness and ability to sleep also indicated that subjects improved on P-552-02 compared to placebo. The work was funded by Parion Sciences under a clinical study agreement with Tufts University.
“We are very encouraged with the outcome of this study. The improvements seen in this safety study, with the low dose and small sample size, demonstrate the potential of this drug candidate to bring relief to a quality of life issue faced daily by these patients,” said M. Ross Johnson, Parion Chief Executive Officer. “Based on these results, we plan to proceed with a Phase I/IIA study designed to test the efficacy of higher concentrations of P-552-02 delivered in a spray formulation and dosing at different intervals, and to pursue other potential indications.”
Epithelial sodium channel blockers, such as P-552-02, are unique therapeutic agents that stimulate and maintain hydration on the body’s mucosal surfaces, including those on the lung, mouth, nose, eye and gastrointestinal tract. Restoring the hydration of mucosal surfaces in the mouth addresses the fundamental problem that causes the extreme dryness of Sjogren’s syndrome.
Sjogren’s syndrome is a chronic disorder that occurs when a person’s normally protective immune system attacks and destroys moisture-producing glands, including the salivary and tear glands. There are currently no specific topical pharmaceutical medications to alleviate the symptoms of dry mouth associated with Sjogren’s syndrome, which can cause difficulty with chewing and swallowing, decreased sense of taste, hoarseness, coughing and an increase in dental cavities.
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 Sjogren’s syndrome, dry eye, certain pulmonary diseases, and diverticulitis and other gastrointestinal diseases, as well as biodefense applications. Parion’s lead product candidate, P-552-02, has completed a Phase I clinical trial in Sjogren’s syndrome and a Phase II clinical trial in cystic fibrosis. In August 2007, Parion announced a collaboration with Gilead Sciences focused on developing drug candidates for pulmonary diseases utilizing Parion’s expertise in epithelial sodium channel blockers. Parion was founded based on technology from University of North Carolina, Chapel Hill (UNC-CH). For more information, please visit www.parion.com
August 15, 2007
For Immediate Release
PARION SCIENCES AND GILEAD SCIENCES SIGN AGREEMENT TO
ADVANCE DRUG CANDIDATES FOR PULMONARY DISEASE
-- Companies Will Initially Focus Research Efforts in Cystic Fibrosis --
DURHAM, NC and FOSTER CITY, CA August 15, 2007 - Parion Sciences, Inc. and Gilead Sciences, Inc. (Nasdaq: GILD) today announced that they have entered into an exclusive licensing and co-development agreement focused on P-680, an epithelial sodium channel (ENaC) inhibitor discovered by Parion, a privately-held, development-stage pharmaceutical company dedicated to treating serious diseases resulting from the failure of the body’s mucosal defenses. The agreement grants Gilead worldwide commercialization rights to P-680 for the treatment of pulmonary diseases, including cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD) and non-CF bronchiectasis. In addition, the companies will collaborate on a research program to identify other promising ENaC blocker-based drug candidates utilizing Parion’s proprietary ENaC-based chemistry platform.
According to the terms of the agreement, Gilead will provide an upfront payment of $5 million for the license and make an additional $5 million investment in Parion. In addition, under the license, Gilead will supply research funding and may make payments upon achievements of certain milestones resulting in a potential deal value of approximately $146 million. Parion will perform the IND-enabling studies for P-680 and will transition development responsibilities to Gilead during the Phase I clinical trial period. Parion will also be eligible to receive up to double-digit royalties based on potential future product sales.
ENaC inhibitors are unique therapeutic agents that stimulate and maintain 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 produces infections in both acquired and genetic forms of chronic lung disease, including COPD and CF.
“This agreement validates the importance of ENaC inhibitors in the treatment of diseases involving defects in the innate defenses of the body’s mucosal surfaces,” said Paul Boucher, Director of Operations of Parion. “This partnership enables us to accelerate our development of P-680 and broaden our research programs. We are pleased to have the support of a company with an outstanding track record in the field of infectious diseases and pulmonary medicine.”
“Gilead is committed to building a pipeline of novel respiratory therapeutics to advance the care of patients suffering from life-threatening diseases, and this partnership complements our program for development of aztreonam lysine for inhalation for treatment of CF-related lung infections,” said A. Bruce Montgomery, MD, Senior Vice President, Head of Respiratory Therapeutics, Gilead Sciences. “We will work closely with Parion to complete preclinical development of P-680 in the hopes of advancing it into clinical studies.”
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, bronchiectasis, Sjogren's Syndrome and dry eye. Parion's lead product candidate, P-552, is currently in a Phase II clinical trial for the treatment of cystic fibrosis and 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 the Cystic Fibrosis Foundation Therapeutics, Inc.
For more information about Parion, please visitwww.parion.com.
For more information about the Cystic Fibrosis Foundation, please visitwww.cff.org.
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. Visit Gilead on the World Wide Web at gilead.com.