Herantis Pharma Posts Positive Phase 1b Results for HER-096
Herantis Pharma has reported positive topline results from its phase 1b trial of HER-096 in people living with Parkinson’s disease, announcing that all primary and secondary endpoints were met.
The company now plans to advance the programme into a phase 2 study in 2026, focusing on efficacy, safety and tolerability in patients at an early stage of the condition.
In the phase 1b trial, repeated 200 mg and 300 mg doses of HER-096 were generally safe and well tolerated. The pharmacokinetic profile aligned with predictions from earlier single-dose studies in healthy volunteers, an important confirmation for dose planning.
Crucially, the study verified that HER-096 crosses the blood–brain barrier in Parkinson’s patients – an essential requirement for any therapy aiming to modify disease course rather than simply treat symptoms.
Based on the data, Herantis has identified a twice-weekly 300 mg regimen as suitable for phase 2 evaluation. The company expects to deliver the full dataset, including exploratory biomarker readouts that may illuminate the drug’s mechanism and potential disease-modifying impact, before the end of 2025.
Those analyses are anticipated to guide final phase 2 design choices and endpoint selection.
The Chairman of the Herantis Scientific Advisory Board said the phase 1b results, taken together with previously reported clinical and preclinical findings, provide a strong rationale for progressing to a phase 2 trial centred on efficacy.
They described the outcome as an important step forward for HER-096 as a highly promising clinical-stage, disease-modifying candidate addressing a clear unmet need in Parkinson’s disease.
Herantis Pharma’s CEO welcomed the milestone, noting that successfully meeting the trial’s primary and secondary endpoints reflects the team’s expertise and ability to execute efficiently.
They extended thanks to the Parkinson’s patients who took part in the study, as well as to contributors and patient organisations – including the Michael J. Fox Foundation and Parkinson’s UK – for their support and engagement.
Looking ahead, they said the company is excited to move into phase 2 as it explores HER-096’s potential to become the first disease-modifying therapy for Parkinson’s.
In Conclusion
With safety, tolerability, blood–brain barrier penetration and a dose roadmap now established, HER-096 advances with growing momentum.
The forthcoming full dataset in 2025 – particularly the exploratory biomarkers – will be pivotal in shaping the 2026 phase 2 efficacy trial. For patients and clinicians seeking treatments that change the trajectory of Parkinson’s disease, these results mark a measured but meaningful step towards that goal.
News Credits: Herantis advances HER-096 after successful Phase 1b Parkinson’s trial
Things you may also like: