Urovant licenses overactive bladder gene therapy hMaxi-K from Ion Channel

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Urovant Sciences has acquired global licensing rights for the development and commercialization of a gene therapy called hMaxi-K from Ion Channel Innovations, which is being developed for the treatment of overactive bladder (OAB) in patients who did not respond to oral pharmacologic therapy.

As of now, there are no treatments for overactive bladder that have been approved by the US FDA.

Overactive bladder is a condition which causes sudden urge to urinate. It may or may not include accidental urinary leakage, and usually involves increased frequency of urination.

hMaxi-K has been assessed in a couple of phase 1 studies in overactive bladder patients. In a phase 1b trial, hMaxi-K used as an intravesical injection in women with overactive bladder symptoms was found to be generally well tolerated.

Urovant licenses hMaxi-K, a gene therapy for overactive bladder from Ion Channel
Urovant licenses hMaxi-K, a gene therapy for overactive bladder from Ion Channel. Image courtesy of dream designs at FreeDigitalPhotos.net.

The findings of the trial, which included 13 patients, revealed dose-dependent improvements in urinary urgency and frequency, with statistical significance achieved in the high dose cohort.

Commenting on acquiring the licensing rights for the overactive bladder treatment, Keith A. Katkin – President and CEO of Urovant Sciences, said: “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.

“Urovant also has access to gene therapy expertise through the Roivant family of companies.”

Urovant Sciences revealed its intentions to discuss with the FDA and launch a phase 2 trial next year to study hMaxi-K as a treatment for overactive bladder patients who were not successfully treated with other pharmacological therapies.

The Swiss clinical-stage biopharmaceutical company had launched a phase 3 trial for vibegron, earlier this year, to evaluate the oral β3-adrenergic agonist as a second-line therapy for overactive bladder with top-line results expected to come out in 2019.