BioXell’s overactive bladder trial fails endpoint

BioXell, an Italy-based biopharmaceutical company, has reported top-line results of its Phase IIb trial of Elocalcitol in patients suffering from overactive bladder.

The overactive bladder (OAB) trial was a urodynamic, multi-center, double-blind, placebo-controlled study in which 257 patients were randomized into three groups (placebo, 75mcg, 150mcg), and treated daily for four weeks.

The primary endpoint was to evaluate the effect of Elocalcitol on bladder volume at the first involuntary detrusor contraction, following four weeks of treatment. Secondary endpoints included additional urodynamic parameters, symptoms severity and patient’s perception of bladder condition. The trial was performed in 47 centers in the UK, the Netherlands, Italy and eastern Europe.

According to BioXell, a statistically significant effect on the primary endpoint, the ‘change in volume at first involuntary contraction’, was not achieved. A statistically significant improvement in ‘bladder volume at first desire to void’ was observed in the intention-to-treat population (ITT). Numerical improvements in most other urodynamic parameters compared to placebo were observed but did not reach statistical significance.

Numerical improvements were also seen for the key symptoms of OAB in all treatment groups. A statistically significant improvement in incontinence episodes was observed in the modified-intention-to-treat population. There was a strong dose related trend in the improvement in patient’s perception bladder condition in the ITT population which reached statistical significance in the per protocol analysis, the company said.

Francesco Sinigaglia, CEO of BioXell, said: The results on the primary endpoint are disappointing. Data on the secondary endpoints are encouraging and we will be discussing the full data set with our experts and investigators in the coming weeks.