First patients dosed in final cohort of Phase 1b clinical trial of HER-096 for Parkinson’s disease

Herantis Pharma Plc – Press release

First patients dosed in final cohort of Phase 1b clinical trial of HER-096 for Parkinson’s disease

• HER-096 is a first-in-class agent in development for the treatment of Parkinson’s disease with disease modifying potential and convenient subcutaneous administration
• Successful completion of the first patient cohort in Part 2 of the trial and approval to proceed from the Data and Safety Monitoring Board
• Primary objective is to assess the safety, tolerability and pharmacokinetics of repeated subcutaneous doses of HER-096; the trial will also evaluate selected biomarkers, discover and identify novel treatment response biomarkers and monitor symptoms associated with Parkinson’s disease
• Topline data from Phase 1b trial is expected in September 2025
• Trial funded by the Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Parkinson’s UK
  
  

Espoo, Finland, 13 May 2025: Herantis Pharma Plc ("Herantis"), a company developing disease-modifying therapies for Parkinson’s disease, today announced the first patients have been dosed in the final cohort of its Phase 1b 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 1b 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.