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Provesica Publishes XEN-D0501 Phase 1 Data on Innovative new Medicine for Overactive Bladder


Oral TRPV1 antagonist well tolerated in repeated dose study and now undergoing phase 2 efficacy trial



CAMBRIDGE, UK – PROVESICA LTD, a clinical-stage urology drug development company, announced today the publication of phase 1 human clinical data on XEN-D0501, the company’s TRPV1 antagonist currently being evaluated in a phase 2 clinical study for the treatment of overactive bladder (OAB). The phase 1 study, published in the British Journal of Clinical Pharmacology1, demonstrated the drug to be safe and well tolerated at doses up to 5 mg twice daily for 14 days. A copy of the paper can be downloaded from


It has previously been reported that some TRPV1 antagonists affect body temperature2. For that reason the XEN-D501 phase 1 study included a detailed assessment of the potential of the drug to raise body temperature as well as other aspects of safety and pharmacokinetics. The study was conducted over 28 days as a placebo-controlled, double-blind, 14-day crossover design, and used ingestible JonahTM capsules and Vitalsense® monitors to record core body temperature accurately and sensitively over the period of the study. No substantial changes in body temperature were observed at any of the three dose levels administered. However, a small, dose dependent increase in core body temperature was detected that was similar to, or less than, normal diurnal variation, attenuated over time and was not considered to be of clinical concern. The results of the study confirmed that XEN-D0501 was suitable for further clinical development, which is now under way.


Commenting on the results, Dr Patrick Round, the lead author, said: “We hope that these data, published in the BJCP, will be of interest to scientists and pharmacologists working on the TRPV1 ion channel. The data clearly demonstrate that XEN-D0501 does not have the body temperature limitations reported for some other TRPV1 antagonists and is well tolerated over a sustained period of dosing.”


XEN-D0501 is currently being assessed for efficacy in overactive bladder in an international phase 2 clinical study at 32 clinical sites in the United Kingdom, Belgium, Russia, Estonia and Romania. The study is assessing the effects of different doses of the drug on OAB symptoms, including urinary frequency, urgency and incontinence. If successful, Provesica will be the first company to demonstrate clinical proof of concept for the TRPV1 mechanism in overactive bladder. 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.


1. Round, P., Priestley, A. and Robinson, J., (2011). “An investigation of the safety and pharmacokinetics of the novel TRPV1 antagonist XEN-D0501 in healthy human subjects”. Brit J Clin Pharmacol, 72: 921-931.

2. Gavva, N.R. et. al., (2008) “Pharmacological blockade of the vanilloid TRPV1 receptor elicits marked hyperthermia in humans.” Pain 136: 202-210.


For further information, please contact:


Tim Brears +44 (0) 1223 493 900

Managing Director

Provesica Limited


Mary Clark, Amber Bielecka, Claire Dickinson +44 (0) 20 7920 2352



About Overactive Bladder:

Overactive bladder (OAB) is a condition that affects over 60 million people in the major seven pharmaceutical economies. It has a huge impact on quality of life. Despite its significance, therapeutic approaches, which mainly rely on the blockade of muscarinic receptors, have a poor side-effect profile and are generally not very effective. There is a clear need for novel therapeutic agents to treat OAB.


About Provesica:

Provesica Ltd is a clinical-stage company developing a novel therapeutic approach to overactive bladder, an area of significant unmet medical need. Provesica’s development compound, XEN-D0501, targets TRPV1, a well-established but not yet exploited mechanism for overactive bladder. Provesica was established in November 2010 as part of the reorganisation of Xention and has raised £5 million from Forbion Capital Partners and Seroba Kernel Life Sciences Ltd to fund the phase 2a study of XEND-0501. Provesica collaborates with Xention in the area of clinical development. For further information, please see


Posted: November 2011