A Phase II study conducted by AltheRx Pharmaceuticals has revealed that its Solabegron drug showed improvements in symptoms of overactive bladder (OAB) compared to placebo.
Solabegron is a 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 Phase II multi-centre randomised double-blind placebo-controlled parallel group study compared 50mg and 125mg dosage strengths of Solabegron to placebo in 258 women with moderate to severe OAB symptoms.
Patients treated with Solabegron 125mg showed a 65.6% reduction from baseline in incontinence episodes and 21% improvement in adjusted mean difference from placebo.
Solabegron-treated subjects also reported a considerable reduction in the frequency of urination and increase in the volume of urine voided over placebo.
The study results also demonstrated that Solabegron 125mg was safe and well-tolerated with no notable changes in any cardiovascular parameters measured by 24-hour ambulatory blood pressure, clinical chemistry, haematology, or ECG parameters.
Roger Dmochowski, Professor at the Department of Urology, Vanderbilt University Medical Center, said, "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," Dmochowski added.
AltheRx plans to begin patient enrolment in the Phase IIb/III study of Solabegron in OAB later this year.
Overactive bladder is a common bladder control problem defined by a set of symptoms including urgency, with or without urge incontinence, usually with frequency and nocturia.
AltheRx Pharmaceuticals is a privately held, clinical development company focused on advancing best-in-class compounds through clinical development and the creation of partnerships with biopharmaceutical companies for commercialisation.