AltheRx reports positive Phase II results of Solabegron for OAB

May 21 2012

AltheRx Pharmaceuticals, a privately-held clinical development company, presented positive results from its Phase II study of Solabegron in overactive bladder (OAB) at the American Urological Association Annual Meeting (Abstract # 520). Solabegron is a novel beta3-adrenoceptor agonist with high affinity and selectivity that is in late stage clinical development for the treatment of OAB and irritable bowel syndrome (IBS).

“The results are encouraging, particularly for patients who found no relief from, or could not tolerate, standard therapy”

The Phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study compared two dosage strengths of Solabegron (50 mg and 125 mg) to placebo in 258 women with moderate to severe OAB symptoms (averaging 4.5 incontinence episodes per day), more than half of whom had unsuccessful prior treatment with muscarinic agents. Solabegron 125 mg, dosed twice daily over 8 weeks, produced a 65.6 percent reduction from baseline in incontinence episodes, a statistically significant adjusted mean difference from placebo of 21 percent.

"The results are encouraging, particularly for patients who found no relief from, or could not tolerate, standard therapy," said Roger R. Dmochowski, M.D., Professor, Department of Urology Vanderbilt University Medical Center. "With a novel mechanism of action, Solabegron may offer an important new treatment modality in OAB that may help us improve patients' symptoms and quality of life. Results of future Phase III clinical trials are awaited to further assess the therapeutic benefits of this compound."

Study results also demonstrated that Solabegron 125 mg was safe and well-tolerated. Adverse events did not differ between the placebo and active treatment groups. Headache and nasopharyngitis were the most frequently reported adverse events across treatment groups with no notable changes in any cardiovascular parameters measured by 24 hour ambulatory blood pressure, clinical chemistry, hematology, or ECG parameters. Urinary retention was not observed.

A Phase IIb/III study of Solabegron in OAB is planned to start enrolling later this year.