Beech Tree Labs Announces Successful Urinary Incontinence Clinical Trial
Providence, RI--(BUSINESS WIRE)--Beech Tree Labs, Inc. announced today that it has completed a successful Phase 2a clinical evaluation of its novel therapeutic agent, UISH001, for treating urinary incontinence (UI). This FDA-authorized study was a multi-site, 67-patient, placebo-controlled trial.
Patients were treated for four weeks with sublingual drops of the test product or placebo. Results showed all test parameters to be in favor of the treatment population, with the most significant (p=0.039) reflecting a decrease in the use of pads for leakage. The test group showed placebo-level side effects.
Complementing the clinical trial outcomes were results from the Cleveland Clinic’s work using the same test formulation with their rat model for urinary incontinence. In this series of trials, statistically significant results were obtained for multiple test parameters, especially in that portion of the study focusing on stress incontinence.
Beech Tree’s founder and CEO, Dr. John McMichael said, “The combined results of this first clinical trial and the Cleveland Clinic outcomes are extremely encouraging. With this data in hand, we are confident that the next trial will provide even more robust results as we are better able to define target populations for a longer trial.”
UI affects 200 million people worldwide, with increasing incidence due to an aging population. There are currently no pharmaceutical drugs on the market to effectively treat stress incontinence, and all UI drugs have limited efficacy and may produce serious adverse effects. The Company’s product candidate for the treatment of UI has demonstrated efficacy in treating urge, stress, and mixed incontinence.
The Company is a leader in molecular signaling technology with an extensive patent portfolio that includes other potential therapeutics targeting a broad spectrum of chronic disorders. Beech Tree Labs is a privately held biopharmaceutical company specializing in discovery and early-stage development through Phase 2 clinical trials and out-licenses to larger pharmaceutical and biotech firms for continued evaluation and marketing.