Roivant Sciences, a global healthcare company focused on realizing the full value of promising biomedical research to improve the lives of patients and their families, announced the formation of Urovant Sciences, a new company focused on developing innovative therapies for urologic conditions.
Urovant’s lead therapeutic candidate is vibegron, an oral β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron (formerly MK-4618) from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
Over 2,700 patients with symptoms of overactive bladder have been enrolled in clinical studies evaluating the safety and efficacy of vibegron, including a completed global randomized, double-blind, placebo- and active comparator-controlled Phase 2b study of over 1,300 subjects that met its primary endpoints and key secondary endpoints, as well as a completed randomized, placebo and active comparator-controlled Phase 3 study of over 1,000 patients conducted outside of the United States that met its primary and key secondary endpoints. Urovant plans to initiate a multinational Phase 3 registration program for vibegron in 2017.
“We are delighted to welcome another ‘Vant’ to our growing family of companies,” said Vivek Ramaswamy, founder and CEO of Roivant Sciences. “Urologic conditions such as overactive bladder adversely impact millions of individuals, and the current treatment options are unsatisfactory for many patients. Our aim is to provide patients with better options as quickly as possible.”
About Overactive Bladder
Overactive bladder (OAB) is a condition that affects potentially 46 million American adults. The most common symptoms of OAB include the experience of sudden urges to urinate that cannot be controlled, frequent urination, and urinary incontinence due to involuntary contractions of the detrusor muscle. While several conditions may contribute to signs and symptoms of overactive bladder, the underlying cause of OAB remains unclear.
Vibegron is an investigational oral β3-adrenergic agonist being studied for overactive bladder (OAB). β3-adrenergic receptors play a role in the bladder fill-void cycle. By stimulating that pathway, vibegron has the potential to relax the bladder detrusor muscle. Relaxing the bladder allows it to store urine more efficiently, thereby decreasing the symptoms of OAB. Over 2,700 patients with symptoms of OAB have previously been enrolled in clinical studies evaluating the safety and efficacy of vibegron.