Preliminary findings of a Phase II clinical trial of Plethora Solutions’ PSD503 indicates that the agent is safe and effective as a front-line therapy for stress urinary incontinence (SUI).

PSD503 is a metered-dose, topical gel formulation of phenylephrine, an alpha agonist that, in oral form, could induce side effects such as tremor, agitation, hypertension, arrhythmias and difficulties in breathing.

In the 12-patient trial, the drug produced a 44% cut in leakage compared to an increase of 11% with placebo, and the response rate in the treatment group was 50%. Moreover, cardiovascular side effect profiles were “indistinguishable” between the placebo and PSD503 arms of the study, and only very low systemic plasma concentrations of phenylephrine were recorded, according to the group.

Substantial market
The firm is obviously very pleased with the results as, it says, they support the commercial potential of the product, which is targeting a patient population of 23 million in North America, France, Germany, Italy, Spain and the UK.

The results “also add substantially to the package of data required for successful out-licensing”, said Dr Steven Powell, CEO of Plethora, adding: “Potential licensing partners have expressed an interest in this programme already and, with this data, we look forward to advancing these discussions.”