Urovant Sciences says its experimental drug for overactive bladder could offer advantages compared to an FDA-approved treatment marketed by Astellas Pharma. But late-stage clinical results released Tuesday raise questions whether Urovant can persuade doctors to prescribe it instead of a much cheaper generic competitor.
Irvine, CA-based Urovant (NASDAQ: UROV) said Tuesday that its drug vibegron hit the main goals of a Phase 3 study. Compared to a placebo, it reduced daily urges to urinate as well as episodes of urination. The difference was statistically significant.
However, the Urovant drug did not achieve statistical significance compared to a third group taking tolteridine, a generic drug, which means vibegron’s better performance was more likely to be chalked up to random chance. Urovant said vibegron’s performance was numerically better than the generic, and that its drug kicked in faster.
The news Tuesday morning sent shares down more than 21 percent to $10.92.
Until investors noticed the drug’s failure to solidly beat the generic competition, the results appeared to be a welcome win for Urovant parent company Roivant Sciences, which has endured a string of clinical trial failures to date. Founded by hedge fund manager Vivek Ramaswamy, Roivant looks for compounds shelved by big pharma companies, licenses them, and advances them through clinical trials. The company has operations in Switzerland, New York, and Durham, NC. In Roivant’s highest profile effort so far, a drug that Roivant subsidiary Axovant Sciences (NASDAQ: AXON) acquired from GlaxoSmithKline (NYSE: GSK) failed twice, first for Alzheimer’s disease in 2017, then in Lewy body dementia last year, leading to an overhaul of Axovant personnel and strategy.
Urovant licensed vibegron from Merck (NYSE: MRK) in 2017 for $25 million. The once-daily pill was developed to target a receptor that plays a role in relaxing the smooth muscle of the bladder, increasing its capacity and reducing symptoms of overactive bladder. Urovant raised $140 million in its IPO last year, most of which was earmarked for Phase 3 tests of vibegron.
Urovant says in securities filings that vibegron could offer a better alternative to mirabegron (Myrbetriq), an Astellas drug approved in 2012 that works in a similar way. While mirabegron has taken market share from older overactive bladder drugs, Urovant says that the Astellas drug is slow to work and is linked to frequent drug-drug interactions.
The Phase 3 test of vibegron enrolled 1,518 men and women with overactive bladder. Patients were randomized to receive vibegron, a placebo, or the generic tolteridine. The main goals of the study were a change from baseline in average episodes of urination per day, and a change from baseline in the average episodes of urges to urinate per day. A small percentage of patients experienced side effects, which included headache, nasal inflammation, diarrhea, and nausea, Urovant reported.
Despite the negative investor reaction, Urovant says it plans to file for FDA approval by early next year. It plans to present the full data from the study at the American Urological Association 2019 annual meeting in May.