Initiator Pharma announces positive results from pudafensine Phase I pharmacokinetic trial

Initiator Pharma A/S, a clinical-stage pharma company developing innovative drugs targeting key unmet medical needs within the central and peripheral nervous system, announced today that it has obtained positive data from a Phase I drug formulation and pharmacokinetics study in healthy subjects evaluating optimized oral solid dosage forms of pudafensine (IP2015), enabling a smooth and efficient bridging between previous data sets into new future clinical studies for pudafensine.

The Phase I study is an open-labeled randomized study of 12 healthy subjects evaluating current and new oral solid dosage formulations of pudafensine. The study demonstrated that the new oral solid dosing formulations provide relevant drug bioavailability and pharmacokinetic drug release profiles supporting the future treatment settings in Phase II and III trials. The reported adverse events were of mild severity and only potentially related to treatment.

“We are now confident in having an ideal future product for patients and a product with strengthened patent protection. As we have communicated previously, we are very convinced of the benefits of pudafensine from the data generated in our clinical trials on erectile dysfunction and its effect on pain in healthy volunteers. This optimized product is an important milestone for us and represents a key deliverable for pudafensine in preparation for its future pivotal registration trials,” says Claus Elsborg Olesen, CEO at Initiator Pharma.