September 2025

Conclusion of the pivotal pharmacokinetic trial 001.

Study INT-001 (Pharmacokinetics Study - PK) – a Phase 1 randomized, open-label, crossover study in 24 subjects (≥ 30 years of age) with advanced PD to investigate the pharmacokinetics (PK) of Lecigon versus Duopa administered with and without entacapone (Comtan). This study has an inherent interim analysis planned and approved by the FDA at 50% enrolment (N=12) for sample size re-estimation. One of the potential outcomes is an early termination should the emerging data be favorable.