Clinical trials

Phase 1b

Herantis announced positive topline results from its Phase 1b trial of HER-096 in people living with Parkinson’s disease, October 2025.  The trial met 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.

About the Phase 1b clinical trial

The Phase 1b clinical study consisted of two parts:

  • In Part 1, 12 healthy volunteer subjects were dosed with a single dose for additional assessment of pharmacokinetic properties of HER-096. Encouraging pharmacokinetic data from this part of the study were announced on 28 January 2025 here.
  • In Part 2, 24 patients with Parkinson’s disease were dosed for twice weekly over a four-week period with either HER-096 or placebo, to study the safety and tolerability of repeated subcutaneous doses of HER-096. The study includes an exploratory biomarker part, including both targeted and untargeted assessments, to evaluate biological responses to HER-096 dosing in humans.

This trial was funded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Parkinson’s UK. It was conducted in Turku and Helsinki, Finland by the contract research organization Clinical Research Services Turku – CRST Oy.

The trial is registered at ClinicalTrials.gov here and at EU Clinical Trials here.

Phase 1a

Herantis announced positive results from its Phase 1a clinical trial in healthy subjects in October 2023.

Topline data overview:

  • Overall good safety and tolerability profile in young and older healthy subjects. As expected, there were mild local injection site adverse events both in the HER-096 and the placebo groups.
  • Plasma pharmacokinetic (PK) profile in humans is well aligned with preclinical data. Maximum plasma concentration reached at the highest dose level (300 mg) was approximately 10 000 ng/ml and the plasma half-life was approximately 2 hours in all dose groups in young subjects and 2.5 hours in older subjects. Elimination of HER-096 occurred mainly via renal excretion as predicted by preclinical studies.
  • HER-096 concentration in cerebrospinal fluid (CSF) reached 50 – 100 ng/ml within 4 – 12 hours after a 200 mg subcutaneous dose of HER-096. This is in the predicted pharmacologically active CSF concentration range and is aligned with the preclinical data.

About the HER-096 Phase 1a clinical trial:

The Phase 1a trial was a randomized, double-blinded, placebo-controlled, safety, tolerability, and pharmacokinetic trial of subcutaneous single ascending doses of HER-096.

  • In part 1 of the trial, a single subcutaneous dose of HER-096 or placebo was administered to young, healthy, male subjects (20-45 years of age) to assess safety, tolerability, and the pharmacokinetic profile of HER-096 (plasma, urine) in six ascending dose groups, 6 dosed with HER-096 and 2 dosed with placebo in each dose group.
  • In the part 2 of the trial, 12 older healthy subjects (50-75 years of age), both males and females, were administered with a single dose of HER-096 to assess safety, tolerability, and the pharmacokinetic profile of HER-096 including blood-brain barrier penetration (plasma, urine, CSF).

In total, the trial recruited 60 healthy volunteer subjects. The trial took place at a single site in Finland and was conducted by the contract research organization Clinical Research Services Turku – CRST Oy.

The trial is registered at ClinicalTrials.gov with an ID NCT05915247.

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