Irvine-based Urovant Sciences Ltd. (Nasdaq: UROV) said on Nov. 24 that its flagship drug vibegron missed its primary endpoint in a phase 2a clinical trial for the treatment of abdominal pain due to irritable bowel syndrome.
The results signal that vibegron, which is expected to receive federal clearance to treat overactive bladder by year’s end, might not be the game-changer that investors, physicians and patients have hoped for.
Vibegron earlier this year met all of its secondary endpoints for its phase 3 clinical trial for the treatment of overactive bladder in women, though there was skepticism on Wall Street that the drug failed to clearly outperform generic medication.
While Urovant’s ability to address irritable bowel syndrome is in doubt given the recent results, it continues to conduct clinical work for other areas of treatment including overactive bladder in men and a bladder condition known as BPH.
One positive is that clinical trials have yet to reveal major safety concerns or risks associated with vibegron.
Urovant’s shares were largely unchanged following the phase 2a results.
Shares of the clinical-stage drugmaker were priced around $16.07 at press time, up 94% since Urovant announced on Nov. 12 its largest shareholder Sumitovant Biopharma would acquire its outstanding shares for about $142 million.Â
The all cash deal placed an approximately $584 million total equity value on Urovant, on a dully diluted basis, the two companies said when announcing the sale.
