Herantis Pharma has dosed the first patients in the final cohort of its Phase Ib clinical trial evaluating the safety and tolerability of HER-096 in patients with Parkinson’s disease.

Commenting on the study, Antti Vuolanto, CEO of Herantis Pharma, said: “Parkinson’s disease is a life altering condition, and there is an urgent need for new treatments that can halt or slow its progression. We are highly encouraged by the potential of HER-096. Its disease-modifying properties combined with its ability to cross the blood-brain barrier makes it a compelling candidate to become a transformative therapy for Parkinson’s that addresses the underlying disease, not just the symptoms. We remain focused on completing the final cohort of this Phase Ib trial and expect to report topline data in September 2025.”

Parkinson’s disease is a devastating neurological condition affecting around 10 million people worldwide, for which there is currently no cure. Existing treatments only address the symptoms and are often associated with significant side effects.

HER-096 is a first-in-class synthetic peptidomimetic designed to mimic the activity of cerebral dopamine neurotropic factor (CDNF) protein, with the capability of effectively crossing the blood-brain barrier allowing for convenient subcutaneous administration. With a multi-modal mechanism of action, HER-096 has the potential to protect against the neuronal degeneration and cell death that cause the symptoms of Parkinson’s disease.

About the Phase Ib study

The Phase Ib clinical study consists of two parts. In Part 1, eight healthy volunteers received a single 300 mg subcutaneous dose of HER-096 to assess its safety and pharmacokinetic properties. Encouraging pharmacokinetic data from this phase were announced on 28 January 2025.

Part 2 is a randomised, double-blind, placebo-controlled part of the trial in patients with Parkinson’s disease, divided into two cohorts. In the first cohort, 12 patients were dosed twice weekly over a four-week period. Of these, eight patients received 200 mg of HER-096 and four received placebo. Based on a review of the data, the Data and Safety Monitoring Board (DSMB) recommended proceeding to the final cohort. In the final cohort, patients will receive 300 mg doses of HER-096 or placebo twice weekly over a four-week period.

The primary objective of the Phase Ib trial is to assess the safety, tolerability and pharmacokinetics of repeated subcutaneous doses of HER-096. Part 2 will also evaluate selected biomarkers and aims to identify novel treatment-response biomarkers in patients with Parkinson’s disease. Symptom progression will be monitored using both Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and with a wearable recording device.

Topline results are expected in September 2025.

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

The Phase Ib trial builds on positive results from the Phase Ia trial, which demonstrated a good safety and tolerability profile, along with effective blood-brain barrier penetration of subcutaneously administered HER-096 in healthy volunteers.

Megan Thomas, Multimedia Editor, DDW