UroGen Pharma: Phase 2 APOLLO Clinical Trial Did Not Meet Primary Endpoint

(RTTNews) - Biopharmaceutical company UroGen Pharma Ltd. (URGN) said Thursday that the Phase 2 APOLLO clinical trial of a RTGel hydrogel formulation in combination with Botox (onabotulinumtoxinA) intravesical instillation in patients with overactive bladder (OAB) and urinary incontinence did not meet the primary endpoint of the trial.

The primary endpoint is the improvement of overactive bladder symptoms, as measured by the reduction in urinary incontinence episodes per day.

According to UroGen Pharma, data from the trial suggested this result may have been due to Botox not effectively permeating the urothelium.

The company added that safety and tolerability were evaluated compared to placebo, as well as the dwell time manifested by hydrogel excretion. The combination was reported to be safe and well tolerated compared to placebo, with extended dwell time for up to 10 hours following initial instillation.

In addition, patients also reported satisfaction with the ease of hydrogel administration which is performed through a standard urinary catheter.

"While we were disappointed with the results of the APOLLO trial, the data are very informative and provide important learnings for future experiments. The topline data from this trial reinforces that our RTGel technology could be combined with a substantial library of molecules to deliver therapy where dwell time may improve outcomes and we look forward to our continued collaboration with AbbVie as they develop their portfolio of toxin proteins," said Dr. Mark Schoenberg, Chief Medical Officer at UroGen.

The Phase 2 trial was conducted by AbbVie under the license agreement entered into with UroGen in October 2016. The agreement granted an exclusive worldwide license to Allergan plc, now an AbbVie company, to research, manufacture and commercialize pharmaceutical products formulated with an RTGel hydrogel formulation and clostridial toxins, including Botox.

The license agreement enables the companies to continue exploration of the RTGel hydrogel formulation in combination with AbbVie's portfolio of clostridial toxins in OAB and other patient populations.

UroGen noted that it is eligible to receive payments from AbbVie on the achievement of certain development, regulatory and commercial milestones, in addition to royalties on potential net sales.