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Velicept Therapeutics Announces Positive Top-Line Phase 2b Results for Solabegron in the Treatment of Overactive Bladder (OAB)

San Francisco, CA USA (UroToday.com) -- 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 that its next generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a Phase 2b study in patients with overactive bladder (OAB). In the study, twice-daily administration of solabegron demonstrated a statistically significant improvement compared to placebo at week 12, as measured by the mean change in number of micturitions per day, the study’s primary endpoint. Solabegron also demonstrated statistical significance across multiple secondary endpoints including percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes.

The 12-week placebo-controlled VEL-2002 study enrolled 435 women ages 18 to 80 suffering from OAB. Solabegron was generally well-tolerated. Treatment-emergent adverse events and serious adverse events were infrequent and comparable between the solabegron and placebo-treated groups. Velicept plans to submit the data from the VEL-2002 study for presentation at upcoming scientific meetings.

“We are encouraged by these positive top-line results for VEL-2002 as they are consistent with what we’ve seen in a prior study with solabegron undertaken by GSK and further validate the potential for best-in-class efficacy and improved safety for patients with OAB,” said James Walker, President and Chief Executive Officer, Velicept Therapeutics. “We look forward to the results of our second study, which will help us finalize our plans for moving forward with a pivotal Phase 3 program early next year.”

Study VEL-2002 further validates solabegron’s potential for best-in-class efficacy across multiple primary and secondary endpoints.

Velicept has also developed a novel, once-daily formulation of solabegron which is being evaluated in an ongoing Phase 2b study (VEL-2001). VEL-2001 has completed enrollment and the company expects to announce top-line results in the second quarter of this year.


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