Urovant may be gearing up for its first commercial launch, but that doesn’t mean it’s taking its eye off the R&D ball. As it builds its commercial organization for its overactive bladder treatment, the company pushing the same drug through the clinic in other indications, and working on a gene therapy, too.
December will be a big month—the FDA is set to decide the fate of Urovant’s lead asset, vibegron, as a treatment for overactive bladder (OAB) by Dec. 26, and the company plans to finish enrolling a phase 2a study for URO-902, a gene therapy also for the treatment of OAB.
Urovant believes that vibegron, a beta-3 agonist, could become a best-in-class therapy to rival Astellas’ Myrbetriq. The company thinks it can win share from the incumbent by showing vibegron acts faster and is safer and more tolerable than Myrbetriq, which carries a warning about hypertension.
But if vibegron is poised to challenge Myrbetriq and offer yet another treatment option for patients with OAB, why pursue a gene therapy?
The short answer is current treatments don’t work for some patients.
The first step to treating overactive bladder, says Urovant CEO James Robinson, is behavioral modification to manage the condition without medicines. Think restricting fluid intake, or a practice called “bathroom mapping,” which, as the name suggests, involves habitually keeping an eye out for bathrooms for when an urge to urinate hits. The next step involves drugs, typically an anticholinergic drug or a beta-3 drug, like vibegron or Myrbetriq.
“As you expect, no medicine works for everybody, so there is this third-line market… Products like botox have been successful in that market because there are patients who don’t respond to conventional therapy,” Robinson, who goes by Jim, said. “Botox demonstrated that patients not only need another option but benefit from this option.”
Urovant sees its gene therapy, URO-902, fitting into that third-line setting. Patients who don’t do well with oral drugs could benefit from a one-and-done gene therapy.
The company licensed the treatment from Ion Channel Innovations in 2018. It is given through a single injection through the bladder under local anesthetic. The company plans to test two dose levels of the gene therapy against placebo in about 80 women over three months. It will first test a lower dose to see if it can reduce the number of urge urinary incontinence episodes per day, said Urovant chief medical officer, Cornelia Haag-Molnteller, M.D. Ph.D., on the company’s first-quarter earnings call Thursday. After it has tested this dose, an independent data-monitoring board will decide if the study should proceed to the higher dose.
Besides OAB, Urovant is chugging along at testing vibegron in other indications, including in patients with pain associated with irritable bowel syndrome (IBS) and in men with OAB and an enlarged prostate, a condition known as benign prostatic hyperplasia, or BPH. It expects to report topline data from the IBS study in November, Robinson said on the earnings call.
Urovant launched out of Roivant in 2017 with vibegron in hand, having licensed the global rights—excluding certain Asian markets—from Merck. The drug works by activating the beta-3 adrenergic receptor, the most common receptor of its kind on the smooth muscle around the bladder. Stimulating this receptor makes those muscles relax, thereby increasing bladder capacity and reducing OAB symptoms, like the urgent and frequent need to urinate and urinary incontinence, or leakage.
It’s testing the drug in irritable bowel syndrome—a seemingly unrelated ailment—because beta-3 isn’t just found in the bladder, but also in the gut, Robinson said.
“If we can relax the smooth muscle of the gut, we have the potential to alleviate the pain that patients are suffering,” he added.
Robinson is no stranger to OAB and beta-3 agonists—before taking the helm at Urovant in March this year, he had, among other things, led operations for Astellas, overseeing the commercial launch of two OAB treatments, including Myrbetriq. His commercialization plan for vibegron includes a three-year exclusive distribution agreement with Sunovion Pharma, a subsidiary of Sumitomo Dainippon that had built a commercial infrastructure to market drugs like the antipsychotic Latuda and the insomnia med Lunesta.
Teaming up with Sunovion also meant keeping it in the family—in September 2019, Roivant sold five of its “vants” to Sumitomo Dainippon for $3 billion upfront. The Japanese pharma put those five biotechs—Myovant, Altavant, Enzyvant, Spirovant and, of course, Urovant—under a new “vant” umbrella, Sumitovant, led by CEO Myrtle Potter.