Herantis Pharma has announced positive topline results from its phase 1b trial of HER-096 in people living with Parkinson’s disease, with all primary and secondary endpoints met. The company now plans to advance the drug into a Phase 2 trial in 2026 to evaluate efficacy, safety and tolerability in early-stage patients.
The trial showed that repeated 200 mg and 300 mg doses of HER-096 were generally safe and well tolerated. The pharmacokinetic profile matched predictions from earlier single-dose studies in healthy volunteers, and crucially, blood-brain barrier penetration was confirmed in Parkinson’s patients.
Data from the study indicate that a twice-weekly 300 mg dosing regimen is suitable for phase 2. The full dataset, including exploratory biomarker data, is expected before the end of 2025.
Anders Gersel Pedersen, Chairman of the Herantis Scientific Advisory Board, said: “The phase 1b results combined with the previously reported clinical and preclinical data provide a good rationale for advancing HER-096 into a phase 2 trial focused on efficacy. This is an important step forward for HER-096 as a very promising clinical-stage disease-modifying drug candidate addressing the unmet clinical need in Parkinson’s disease.”
Antti Vuolanto, CEO of Herantis Pharma, explained: “We are thrilled to achieve this important milestone, successfully meeting the trial’s primary and secondary endpoints. These results are a testament to our team’s expertise and dedication, demonstrating our ability to drive the development program forward efficiently.
“We sincerely thank the Parkinson’s patients participating in this trial, other contributors, and patient organisations, the Michael J. Fox Foundation and Parkinson’s UK, for their support and engagement in this study. We are now excited to advance this program to phase 2 as we explore HER-096’s potential to become the first disease-modifying therapy for Parkinson’s disease.”
