Urovant adds gene therapy to overactive bladder pipeline | Digital Science
Urovant Sciences is no longer a one-trick pony, picking up the global rights to a gene therapy from Ion Channel Innovations. The treatment, which has been tested in phase 1, is being developed for patients with overactive bladder (OAB) for whom oral drugs do not work.
The treatment, hMaxi-K, joins vibegron, a phase 3 OAB drug that Urovant licensed from Merck. HMaxi-K has been tested in two phase 1 studies, including as an injection directly to the bladder in women with OAB symptoms. The latter study, a phase 1b trial, involved 13 patients and found dose-dependent improvements in urinary urgency and frequency, Urovant said in a statement.
“We are pleased to add the gene therapy hMaxi-K to our clinical development portfolio. We are eager to study the potential of hMaxi-K as an alternative therapy for OAB patients who are not getting adequate relief from other therapies,” said Urovant CEO Keith Katkin, in the statement.
There is no approved gene therapy for OAB. Urovant will meet with the FDA as it plans to kick off a phase 2 study in 2019. It hopes to push hMaxi-K as a new treatment for patients who have not responded to other treatments.
Urovant launched in June 2017 with the worldwide rights—excluding those in Japan and some other Asian countries—to vibegron, a selective beta3-adrenergic agonist. Barely a year later, in July, the company filed to raise up to $150 million in its IPO, which will bankroll vibegron’s journey through the clinic. Urovant has started a phase 3 trial testing vibegron in men with OAB and benign prostatic hyperplasia, or an enlarged prostate gland, and will also test it in a phase 2 trial involving patients with IBS-associated pain.
The company expects to report topline phase 3 data next year. Vibegron has already put up some positive phase 2b and phase 3 data, so if the latest trial is positive, Urovant should be able to move ahead with regulatory filings. If all goes well, it could compete with Astellas’ Myrbetriq (mirabegron), the first beta-3 adrenergic agonist to reach the market for OAB.