Initiator Pharma A/S announced 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.