Herantis Pharma presents positive topline data for HER-096 in Phase 1b trial for people living with Parkinson’s disease

Herantis Pharma announces positive topline data for HER-096 in Phase 1b trial for people living with Parkinson’s disease

Trial meets all primary and secondary endpoints establishing a strong foundation to Phase 2 

• The clinical trial demonstrated that both repeated 200 mg and 300 mg doses of HER-096 are generally safe and well tolerated in Parkinson’s disease (PD) patients.
• Results from the clinical trial demonstrated a pharmacokinetic profile consistent with predictions from the single-dose studies in healthy volunteers. Importantly, blood-brain barrier penetration was confirmed in Parkinson’s disease patients.
• Data indicate that twice-weekly dosing regimen with 300 mg dose is suitable for a Phase 2 trial.
• Phase 1b safety, tolerability, and pharmacokinetic data strongly support advancing HER-096 into a Phase 2 trial to assess efficacy.
• The full dataset, including exploratory biomarker data, is expected before the end of 2025.
• Herantis will hold a webcast on October 8^th, at 13:00 EEST. Link to the webcast: https://herantis.videosync.fi/phase-1b-data-readout

Espoo, Finland, 7 October 2025: Herantis Pharma Plc ("Herantis"), a clinical-stage company developing disease-modifying therapies to stop the progression of Parkinson’s disease, today announces 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. Based on these encouraging Phase 1b results, Herantis intends to advance HER-096 into a Phase 2 clinical trial during 2026 to evaluate the efficacy, safety and tolerability of HER-096 in early-stage Parkinson’s patients.

“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,” commented Anders Gersel Pedersen, M.D, Chairman of Herantis Scientific Advisory Board, formerly Director at Eli Lilly and Company, and EVP at Lundbeck. 

“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 organizations, 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,” said Antti Vuolanto, CEO of Herantis Pharma.