BioXell Plans Phase IIb European Trial for Elocalcitol in Overactive Bladder
BioXell S.p.A. announced its plans to proceed with a Phase IIb clinical trial of its lead compound Elocalcitol in overactive bladder (OAB). Enrolment in the pan-European study is scheduled to begin in early 2007. Details of the study design are currently being finalised.
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.
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