Parion Sciences Announces Phase I Clinical Results For Novel Dry Mouth Treatment

Main Category: Endocrinology
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 08 Apr 2008 - 0:00 PDT

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Parion Sciences, Inc., a privately-held, development-stage pharmaceutical company dedicated to treating diseases resulting from the failure of the body's mucosal defenses, 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 http://www.parion.com

Parion Sciences, Inc.
http://www.parion.com