March 19, 2018
Velicept Therapeutics Initiates First of Two Phase 2b Dose-Ranging Studies of Solabegron in Patients with Overactive Bladder (OAB); Finalizes Novel, Once Daily Formulation; and Receives U.S. Patent Covering OAB
-First study has begun enrolling patients to evaluate twice-daily formulation-
-Second study to begin in the second quarter to assess once-daily dosing with the novel QD formulation-
-Issuance of U.S. Patent No. 9,907,767 further expands Velicept’s patent portfolio covering Solabegron-
MALVERN, PA – March 19, 2018 – Velicept Therapeutics, a privately-held specialty pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced the initiation of the first of two Phase 2b clinical studies. The first study (VEL2002) will evaluate two doses of solabegron dosed twice daily in patients with overactive bladder (OAB). The primary objective of the study is to evaluate the mean change in number of micturitions per day as measured by patients in an e-diary.
The Company has finalized a novel once daily formulation of solabegron which will be evaluated in a second study. The formulation was engineered to optimize efficacy in a convenient once daily dosing. This study (VEL2001) will initiate patient enrollment in the second quarter of this year.
Additionally the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 9,907,767, which is directed to methods related to the use of solabegron to treat overactive bladder. The patent issued with 42 claims directed to methods of treating overactive bladder, measured by an increase in voided volume, using a therapeutically effective amount of solabegron or its derivatives. This issued U.S. Patent is part of a robust intellectual property portfolio that includes numerous issued patents and pending patent applications in the U.S. and major international markets directed to solabegron, its use for the treatment of overactive bladder, once daily formulations designed to optimize patient convenience and efficacy and methods of manufacture.
“We are pleased to be enrolling patients into the first of two dose ranging studies. Driving the program forward with the novel once daily formulation of solabegron as well as expanding our intellectual property estate are key steps for Velicept as we work to deliver an optimal therapy to patients suffering from OAB,” said James Walker, President and Chief Executive Officer, Velicept Therapeutics. “Many patients who suffer from overactive bladder do not achieve adequate relief on existing therapies, so we have designed our development program to maximize potential treatment options for physicians and their patients.”
The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study will enroll 375 adult women ages 18 to 80 with signs and symptoms of overactive bladder from 90 centers across North America. Patients will receive either 125mg or 175mg of solabegron twice daily or placebo for 12 weeks.
Solabegron is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). A Phase II study of solabegron in OAB, previously conducted by GlaxoSmithKline, evaluated a twice-daily dose in 258 patients with moderate to severe incontinence experiencing an average of 4.5 wet episodes per day. Results demonstrated a statistically significant improvement with solabegron as compared to placebo. Furthermore, the Phase II study also indicated a safety and tolerability profile for solabegron that was similar to placebo.
Velicept Therapeutics, Inc. is a privately held, clinical development company focused on advancing best-in-class compounds for the treatment of urological and gastrointestinal disorders. Its lead product, solabegron, is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). For more information, visit www.velicept.com.
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Mike Beyer, Sam Brown, Inc.