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."
For more information:
Gustav H. Gram, CEO
ghg@pilapharma.com
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 August 2026, the Company had a clinical trial application approved for a new 12-week clinical trial in people living with obesity. The Company was moreover holds an orphan drug designation ("ODD") for XEN-D0501 as a treatment for the painful rare disease erythromelalgia.
This information is information that PILA PHARMA is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-10-12 15:55 CEST.
