Provesica Starts Phase 2 Study in Overactive Bladder
Product News Apr 21, 2011
Provesica Ltd, has announced that it had initiated a Phase 2 study of overactive bladder with its lead product XEN-D0501.
XEN-D0501 is an antagonist of the TRPV1 receptor which is expressed both in the bladder and on the afferent nerve pathway. The compound has shown promising efficacy in pre-clinical models of overactive bladder and recently completed Phase 1 clinical trials and was shown to be safe and well tolerated.
The Phase 2 study will aim to recruit 180 evaluable subjects suffering from overactive bladder at 26 clinical sites in the United Kingdom, Belgium, Russia, Estonia and Romania.
The study will assess the symptoms of OAB such as frequency, urgency and incontinence. The first patients have now been enrolled into the study.
Commenting on the news Tim Brears, Managing Director of Provesica, said: ‘Starting this study is an important step forward for Provesica. XEN-D0501 targets TRPV1, a well-established but not yet exploited mechanism for overactive bladder, and, if successful, we will be the first to demonstrate clinical proof of concept for this mechanism. We are therefore very excited to be playing a leading role in the development of novel overactive bladder therapeutics with a potential first-in-class drug’.
Overactive bladder represents an area of huge unmet medical need affecting over 60 million people in the major seven pharmaceutical economies. It has a substantial impact on quality of life, but despite its significance, current therapeutic approaches have a poor side-effect profile and are generally not very effective.