After the great Axovant implosion that swept away its highly touted Alzheimer’s drug, Roivant chief Vivek Ramaswamy needed one of the biotechs in his fast-growing league of drug developers to win a big Phase III trial. Based on today’s top-line release for Urovant’s Phase III urinary incontinence drug vibegron, the team is claiming that victory and prepping an application for the FDA.
But there are some lingering questions about the cheap generic that was used as an active comparator in the study, and it’s driving the biotech’s stock into the red Tuesday morning.
Urovant’s drug hit statistical significance for both co-primary endpoints and all 7 secondaries when compared against a placebo. But the drug was also tested alongside an old generic drug called tolterodine. And there the research showed that vibegron “achieved numerically better efficacy that tolterodine.”
In the slide show presentation this morning, the company went on to illustrate the specifics of the comparator arms versus placebo, but researchers did not run a p value for the Urovant drug against the generic. But they were relatively close, as you can see here:
Urovant’s drug cut instances of incontinence by 2 from a baseline of 3.43, achieving a clear win over the 1.4 drop in the placebo arm. Tolterodine, though, came much closer at 1.8. Both drugs beat the placebo with statistical significance.
For urination frequency, there was a similar spread. The placebo arm hit a drop of 1.3, with a negative 1.8 for vibegron and -1.6 for tolterodine. Vibegron hit statistical difference versus placebo, tolterodine did not. But there was no direct comparison of the experimental drug and the cheap placebo.
In their announcement back in 2012, Astellas posted these responses for Myrbetriq.
Myrbetriq 25 mg, incontinence episodes were reduced by 1.36 episodes from a baseline of 2.65, a statistically significant reduction of 0.40 vs. placebo in 12 weeks. The number of urinations was reduced by 1.65 urinations from a baseline of 11.68, a statistically significant reduction of 0.47 vs. placebo in 12 weeks.
Myrbetriq 50 mg, incontinence episodes were reduced by 1.49 episodes from a baseline of 2.71, a statistically significant reduction of 0.40 vs. placebo in 12 weeks. Number of urinations was reduced by 1.75 urinations from a baseline of 11.70, a statistically significant reduction of 0.55 vs. placebo in 12 weeks.
You can be sure that analysts will also be filling in the blanks by extrapolating the head-to-head comparisons themselves.
Urovant’s pitch is built around demonstrating a better safety and efficacy profile than the anticholinergics — like tolterodine, where there’s been a link with dementia — and the blockbuster drug Myrbetriq (mirabegron), which was launched by Astellas back in 2012. Vibegron is a beta-3 drug, like Myrbetriq, which is backed by patents that expire in 2023 — about 3 years after Urovant could expect an approval.
Given that this drug is intended for a mass market with millions of patients, teasing out the specifics of how a new, branded drug compares to well established marketed drugs would be crucial to its longterm success or failure on the market.
Urovant, which has a market cap of $442 million, is letting it all ride on this Phase III. Ramaswamy nabbed the drug from Merck with a small, $25 million upfront — one of a slate of deals he struck early on as he grabbed therapies that had been sidelined at the majors and aimed them for quick catalysts.
Big gamble? Jefferies’ Biren Amin noted that a clear win here would be worth a 100% spike in the stock, with a negative outcome eliminating up to half of its market cap.
That’s not what happened, though. After popping up 20% before the bell, the stock turned south, plunging to a minus 17% as investors tried to sort out the results for themselves.
Image: Vivek Ramaswamy at the US-China Biopharma Innovation & Investment Summit, 2018. PHARMCUBE, ENDPOINTS
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