Vivek Ramaswamy's Urovant Headed to FDA With Vibegron After Positive Phase III Data

illustration of Bladder in transparent human abdomen

It’s safe to say that Vivek Ramaswamy, who runs a slate of “Vant” companies under his Roivant umbrella company, could use a win. The former hedge fund manager turned biotech entrepreneur, currently 33 years old, launched Roivant Sciences, then proceeded to develop a group of companies under Roivant, often built on cast-off drugs abandoned by other companies. Ramaswamy’s earlier philosophy was these drugs could be re-developed for different populations or subpopulations, and since he bought them cheap, it seemed like a new business model for biotech.

That philosophy, although probably not dead, took a major hit in September 2018 when one of the companies, Axovant Sciences, had a dramatic failure of its intepirdine in Alzheimer’s disease. Ramaswamy had picked up the drug from GlaxoSmithKline after four failed trials for $5 million and attempted to prove it could be effective with Aricept (donepezil) in an early-stage disease subpopulation. The trial was a disaster. Since then, Roivant and Axovant have restructured and retooled, with Axovant investing in a few promising neuroscience drugs.

But now it looks like Ramaswamy may be on the edge of his first big success, with Urovant Sciences. The company announced positive topline results from its Phase III EMPOWUR trial of vibregron in patients with overactive bladder.

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Vibregon is a once-daily oral beta-three adrenergic agonist the company picked up from Merck when the big pharma company decided to leave the urology market. The drug met its co-primary endpoints at week 12, hitting statistical significance over placebo on decreasing daily urge urinary incontinence (UUI) and decreasing daily microuritions. It was statistically significant as early as the second week, which was the first measured timepoint for both indications. Statistically significant efficacy was seen at all timepoints measured throughout the study.

In addition, all seven pre-specified key secondary endpoints were met. These included reduction in daily urgency episodes compared to placebo. The drug was well tolerated, and the most common side effects were headache, nasopharyngitis, diarrhea and nausea.

Based on the data from this trial, Urovant plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by early 2020.

“There is a significant need for innovative new treatment options for OAB patients, as many patients were unable to find relief with currently available medicines,” stated David R. Staskin, a urologist with St. Elizabeth’s Medical Center and an Associate Professor of Urology at Tufts University School of Medicine in Boston. Staskin is one of the key investigators in the EMPOWUR study. “The strong efficacy and safety topline results from the EMPOWUR study suggest that vibegron, if approved by the FDA, could provide an exciting next-generation treatment option for patients suffering from OAB.”

Overactive bladder is characterized by the sudden urge to urinate that is hard to control, with or without urge urinary incontinence, and usually with increased frequency. In the U.S., more than 30 million people over the age of 40 are diagnosed with bothersome OAB.

STAT notes, “Achieving his first drug-development win—and likely first regulatory approval—with a new overactive bladder treatment may seem like a consolation prize for Ramaswamy. But there’s good money to be made in taming the excessive urge to urinate: Myrbetriq, marketed by Astellas, delivered $750 million in sales last year and is still growing.”

Urovant will release more details about the trial at an upcoming medical conference. Some of the patients in the trial were treated with tolterodine, a generic drug for overactive bladder. Others received vibegron while others were on a placebo. Urovant notes that vibregon only showed marginal improvement over tolterodine, which could be a problem if the drug is approved and needs to compete with a cheap generic. However, the study did show that the side effects of vibregon and placebo, which were similar, were both lower than for tolterodine.

When Urovant went public in September 2018, raising $140 million, shares traded at $14, but quickly dropped to $4. Shares closed Monday at slightly under $14 before the announcement, but dropped again after today’s announcement, currently trading at slightly under $11 per share.

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