DURHAM, North Carolina -- Parion Sciences, Inc. has announced preliminary results from a Phase I clinical safety study of a 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 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 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," said M. Ross Johnson, Parion Chief Executive Officer. "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. 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.
Parion Sciences is a privately held, development-stage pharmaceutical company dedicated to treating diseases resulting from the failure of the body's mucosal defenses.
For more information, go to Parion Sciences.
To read more about dry mouth treatment, go to dry mouth.
