Additional Funding to Advance Phase 2b Development Program in OAB-
Enrollment for Second Phase 2 Study Well Underway-
Issuance of U.S. Patent No. 10,065,922 Further Expands Velicept’s Portfolio Covering Solabegron
MALVERN, Pa. - Velicept Therapeutics, a privately-held clinical stage pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced today it has closed on the expansion of a Series B financing bringing an additional $15 million to support completion of the two ongoing Phase 2b studies, as well as Phase 3 enabling work. The financing led by Samsara BioCapital, included existing investors CDK Associates, LLC; Fountain Healthcare Partners Fund II, L.P.; Longitude Venture Partners II, L.P; and founding investor Becker Ventures. Cory Freedland, a Principal with Samsara BioCapital, has joined the Company’s Board of Directors.
“We are pleased with our progress in advancing the development of solabegron. This financing provides us the capital necessary to complete the robust Phase 2 program and ready the program to enter Phase 3,” said Dr. James Walker, President and Chief Executive Officer, Velicept Therapeutics. “These are important steps as we continue to execute on our plan to deliver an improved next generation therapy to women and men suffering from overactive bladder.”
Velicept also announced that VEL2001, the second of two Phase 2b clinical studies designed to evaluate two doses of a novel once daily time-dependent release formulation of solabegron in patients with overactive bladder (OAB), was initiated in July with enrollment progressing to plan. 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 formulation was engineered to optimize efficacy in a convenient once daily dose. Together with the BID study currently underway (VEL2002), the comprehensive Phase 2 program will explore the full dose range for solabegron with the goal of delivering best in class efficacy in the treatment of OAB.
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 low or high dose of solabegron once daily or placebo for 12 weeks.
Additionally, the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,065,922 with 126 claims, directed to solid solabegron zwitterion. The patent will expire February 23, 2037, inclusive of patent term adjustment. This issued U.S. Patent is part of an intellectual property portfolio, which includes other issued patents, and numerous patent applications in the U.S. and major international markets directed to solabegron for the treatment of OAB.
Solabegron is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). A Phase 2 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 2 study also indicated a safety and tolerability profile for solabegron that was similar to placebo.
Velicept Therapeutics, Inc. is a privately held, clinical stage pharmaceutical 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, 312-961-2502