Urovant Sciences Ltd (NASDAQ:UROV) Q1 2019 Earnings Conference Call - Final Transcript
Aug 13, 2019 • 04:30 pm ET
Keith A. Katkin
Assuming an acceptable safety profile, we will then move into part two of the study in the fourth quarter of this year, an important milestone given there is currently no approved treatment for concomitant OAB and BPH. Additionally, the Phase 2a trial for a vibegron for IBS-related abdominal pain continues to roll on schedule with results expected in 2020. And lastly, we've finalized the Phase 2a protocol for our novel gene therapy product for OAB, URO-902 and are preparing to start enrollment for that study by the end of the fourth quarter of this year.
With that, I'll now turn the call over to our Chief Medical Officer, Dr. Cornelia Haag-Molkenteller, who will provide more detail to our clinical programs.
Thank you, Keith. As mentioned, we continue to make excellent progress across all four of our clinical development programs. First, I will talk about the OAB program for vibegron. We continue to make great progress on the vibegron NDA filing. Following the positive top line results from the Phase 3 EMPOWUR study of certain malignant vibegron for overactive bladder, we're now pleased to report that we've achieved the primary endpoint for the ambulatory blood pressure study. The purpose of the study was to rule out an effective vibegron relative to placebo on daytime systolic blood pressure. The primary endpoint there was the change from baseline to day 28 in mean daytime ambulatory systolic blood pressure. The protocol was reviewed by the FDA in the fall of 2018.
The protocol predefined that for an affected vibegron, I mean, ambulatory systolic blood pressure to be ruled out the upper limit of the 90% confidence interval had to be less than 3.5 millimeter mercury for the daytime ambulatory systolic blood pressure for vibegron compared to placebo. The study enrolls 214 subjects across ten US sites. In accordance with FDA guidance, the study population has similar characteristics as the drug target population. Men and women aged 40 years to 75 years with OAB, this was a controlled study of 75 milligram versus placebo in a one-to-one randomization. The study was based on the 75 milligram vibegron dose plan of registration with the FDA. The duration of the study was four weeks and ambulatory 24-hour blood pressure, post measure that baseline [Indecipherable] 2 and 4.
Secondary endpoints with the change from baseline in mean daytime diastolic blood pressure heart rate and the full 24 hours change in systolic and diastolic pressure and heart rates as well as the maximum changes 30 minutes to 6.5 hours post dosing. A total of 108 subjects were involved into the placebo group, 106 subjects into the vibegron treatment group. 76 of the subjects were female and the main age was 59 years. 97% of the subject completed study. The results of the ambulatory blood pressure study are as follows. The primary study endpoint was achieved for vibegron. The vibegron minus placebo leads for, I mean, a change for the daytime ambulatory blood pressure from baseline to day 28 was