30 September 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 subject first visit (FSFV) for the Part 1 (safety) of PP-CT04 has been enrolled. In total 6 subjects were screened on the first day.
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. This 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.
For more information:
Gustav H. Gram, CEO
PILA PHARMA’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser.
Contact: M: ca@aqurat.se -
T: +46 (0)8 684 05 800
About PILA PHARMA AB (Publ)
PILA PHARMA AB is a Swedish clinical stage biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 antagonists as a novel treatment of obesity and diabetes. The Company owns a TRPV1 asset with data and chemical entities including the clinical development candidate XEN-D0501. In July 2022, the Company was moreover awarded orphan drug designation ("ODD") for XEN-D0501 as a treatment for the painful rare disease erythromelalgia.