12 October 2026, Malmö, Sweden: PILA PHARMA AB (publ)(FN STO: PILA)(FRA: 5KC), a clinical stage biotech company pioneering development of an oral TRPV1 antagonist as a potential first-in-class treatment for obesity and diabetes, today announces that the first two subjects have received their first doses today, comprising of 1 on active and 1 on placebo treatment.
PP-CT04 is a two-part, randomised, double-blind, placebo-controlled, parallel-group, 12‑week trial investigating the safety, tolerability, pharmacokinetics and efficacy of XEN-D0501 in obese participants.
The trial is designed to explore a within-subject dose titration approach to reach anticipated therapeutic plasma concentrations of XEN-D0501 not previously investigated.
Dose escalation will be carried out individually for each participant, beginning at 4 mg BID and increasing stepwise up to a maximum of 16 mg BID. Each dose level will be administered for 1 week, resulting in a maximum dose escalation period of 4 weeks. Once the highest tolerable dose has been reached and confirmed to be tolerable, the participant will continue treatment at that dose for an 8-week maintenance period.
PP-CT04 is divided into two parts with the same overall design, but Part 1, as a pilot safety cohort with 8 participants, entails more intense safety monitoring. The trial is done in collaboration with Clinical Trial Consultants AB.
Part 2 may start once all participants in Part 1 have been dosed for at least 5 weeks and once a favourable recommendation has been given by the internal safety review committee.
CEO Gustav H. Gram comments:
“These weeks we take step after step from preparation to active execution. The fact that the first subjects have now been dosed, is an important milestone the clinical development of our oral TRPV1 antagonist, and it will help us understand how XEN-D0501 is tolerated at higher doses and over a longer duration of treatment, in the population we are developing it for.”