However, the company believes the trial provided the information necessary to proceed with development of the product.
The primary endpoint was improvement in pain and urgency at the end of the study. The study showed that U101 was well tolerated, with an adverse event profile comparable to that of placebo.
U101 showed a 70% response rate with active drug versus a 16% response rate in patients on placebo. An analysis of all subjects in the trial showed a significant improvement in urinary urgency. Furthermore, there was a trend toward improvement in pain in all subjects but this did not achieve statistical significance.
Urigen commented that analysis of the pain component of the primary endpoint was hampered because a substantial number of patients entered into the trial had minimal or transient pain.
Urigen believes the overall results of the trial may have been compromised by issues of patient selection. The company believes it understands the reasons for differences between the phase IIa and phase IIb clinical trial results and that incorporation of appropriate protocol changes will allow it to achieve positive results in subsequent trials.