AltheRx Presents Positive Phase II Results of Solabegron in Overactive Bladder at the European Association of Urology Congress
- Solabegron produced statistically significant improvements in symptoms of overactive bladder (OAB) compared to placebo and was safe and well-tolerated
- Solabegron, a novel beta3-adrenoceptor agonist with high affinity and selectivity, is also in clinical development for the treatment of irritable bowel syndrome (IBS)
- A Phase IIb/III trial of Solabegron in OAB is planned to start later this year
MALVERN, Pa.--(BUSINESS WIRE)--Mar 1, 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 European Association of Urology Congress in Paris (Abstract #685). 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 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 (p=0.025). Patients treated with Solabegron also reported a significant reduction in the frequency of urination (-0.8; p=0.036), and a marked and significant increase in the volume of urine voided (+27%; p<0.001) both compared to placebo.
“These are very encouraging results, particularly for patients who found no relief from 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.
About Overactive Bladder
Overactive bladder (OAB) is a common bladder control problem that affects an estimated 80 million people worldwide, including more than 35 million Americans. The symptoms of OAB include an urgent need to urinate, frequent urination, and sometimes leaking urine before reaching the toilet, a condition also known as urge incontinence. The condition can have an extremely negative impact on a person's quality of life, affecting work, social activities, sexual intimacy and self-esteem.
About AltheRx Pharmaceuticals
Formed in 2010, AltheRx Pharmaceuticals is a privately held development company whose business model is to advance projects through clinical development and create partnerships with biopharmaceutical companies for commercialization. The Company's first product, Solabegron, is a highly selective and potent beta3-adrenoceptor agonist in development for the reduction of symptoms of Overactive Bladder and Irritable Bowel Syndrome. For more information, visit www.altherx.com.
Contact: Company Contact:
Shawn Patrick O'Brien, 484-395-2432
Sam Brown Inc.
Mike Beyer, 773-463-4211
Posted: March 2012