Urovant's lead drug disappoints in mid-stage study as first big FDA decision looms
Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.
In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.
There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.
Even though the drug did somewhat better in a key secondary endpoint — namely responders on the Global Improvement Scale — the 42.4% to 33.3% difference wasn’t enough to qualify for statistical significance.
“Disappointed,” Urovant CMO Cornelia Haag-Molkenteller is ready to shift focus to the rest of the development plan.
“We look forward to advancing our Phase 3 program for vibegron in men with overactive bladder and benign prostatic hyperplasia (BPH), as well as our Phase 2a program for URO-902 in OAB,” she said in a statement.
The biotech said it will continue to analyze the full dataset, without committing to any next steps.
A once daily pill designed to agonize beta-3, vibegron is the key program for Urovant, which recently fully migrated from Roivant to Sumitovant, the new umbrella structure Vivek Ramaswamy set up with Sumitomo Dainippon, in a deal valued at $584 million.
It claimed a Phase III win back in March 2019 when it hit both co-primary endpoints and 7 secondary endpoints compared to placebo. But questions remained over its potential efficacy over a cheap generic called tolterodine used as an active comparator.
Ramaswamy, a flamboyant deal engineer with a checkered record, originally bought the drug from Merck for $25 million.