BioXell Plans Phase IIb European Trial for Elocalcitol in Overactive Bladder
The new study follows the successful completion of a Phase IIa trial of Elocalcitol in 114 patients with OAB, announced in May, in which Elocalcitol demonstrated numerical superiority on its primary endpoint and statistically significant efficacy in several clinically relevant subgroups compared to placebo. Evidence was also obtained for efficacy of Elocalcitol in nocturia and incontinence, symptoms commonly associated with OAB. The Phase IIb trial is intended to confirm key findings from the previous study in a larger patient group.
"We are pleased with the promising results we have seen with Elocalcitol in symptoms where it is generally difficult to show efficacy," remarked Enrico Colli, Chief Medical Officer and Head of R&D at BioXell. "It is a logical next step for us to proceed with a robust Phase IIb study to confirm all these positive signals in a large scale study which could potentially be used as one of our pivotal trials."
The new Phase IIb trial will be the second for Elocalcitol in a urological indication. A Phase IIb trial in Benign Prostatic Hyperplasia (BPH) is currently underway, with a total enrolment of over 500 patients. The results are expected in 2007.
Most read news
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.