CHADDS FORD, Pa.--()--AltheRx Inc., a privately-held clinical development company, announced today that it has purchased all assets related to Solabegron from GlaxoSmithKline. Solabegron is a highly selective and potent beta3-adrenoceptor agonist that has demonstrated positive results in Phase II clinical programs for the treatment of Overactive Bladder (OAB) in women and Irritable Bowel Syndrome (IBS). Solabegron also demonstrated a favorable tolerability profile across all Phase II studies.
“Solabegron is an outstanding primary product for AltheRx. The clinical data suggest that the novel mechanism of Solabegron has the potential to address the needs of patients suffering from OAB and IBS.”
“AltheRx’s business strategy is to acquire novel products aligned with our core expertise, and efficiently advance them through development,” said Shawn O’Brien, Chief Executive Officer of AltheRx Pharmaceuticals. “Solabegron is an outstanding primary product for AltheRx. The clinical data suggest that the novel mechanism of Solabegron has the potential to address the needs of patients suffering from OAB and IBS.”
Solabegron, discovered by GlaxoSmithKline, relaxes bladder smooth muscles by stimulating beta-3 receptors, a novel mechanism as compared to currently available treatments. In the Phase II OAB study, Solabegron was studied in 258 patients with moderate to severe incontinence experiencing an average of 4.5 wet episodes per day. Study results demonstrated a significant improvement with Solabegron as compared to placebo as measured by the reduction of the number of wet episodes and the number of voids per day. In IBS, a Phase II study evaluated 102 patients indicated that Solabegron demonstrated significant reduction in pain associated with IBS and a trend for greater improvement in the quality of life compared to placebo. Both Phase II studies indicated a tolerability profile for Solabegron that was similar to placebo.
“We are currently planning to advance the OAB clinical development program for Solabegron into Phase III later this year,” said Eliot Ohlstein, AltheRx Chief Scientific Officer and former Senior Vice President of the Urology and Cardiovascular CEDD at GlaxoSmithKline. “In IBS, we are focused on creating a Phase IIb clinical program that is aligned with recent guidance from the FDA on developing drugs for IBS.”
About Overactive Bladder and Irritable Bowel Syndrome
Overactive Bladder (OAB) is a common bladder control problem that affects more than 35 million Americans1. Approximately 55 million Americans experience symptoms of Irritable Bowel Syndrome (IBS),2 characterized by abdominal pain and disturbed bowel function. Both conditions can have a negative impact on patients’ quality of life, affecting work, social activities, sexual intimacy and/or self-esteem. About 75 percent of Americans suffering from OAB are not taking a prescription medication3 and up to 70 percent are not receiving medical care for their IBS symptoms.4
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.
3 McVary, Kevin, et. al. European Urology (2009) http://www.renalandurologynews.com/study-most-oab-cases-go-untreated/article/163219/
4 The National Digestive Diseases Information Clearinghouse - http://digestive.niddk.nih.gov/ddiseases/pubs/ibs/#treatment