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

Core Viewpoint - Herantis Pharma Plc has initiated the final cohort of its Phase 1b clinical trial for HER-096, a potential disease-modifying therapy for Parkinson's disease, with the first patients dosed, aiming to report topline data by September 2025 [3][4][9]. Group 1: Clinical Trial Details - The Phase 1b trial consists of two parts: Part 1 involved eight healthy volunteers receiving a single 300 mg subcutaneous dose to assess safety and pharmacokinetics, while Part 2 is a randomized, double-blind, placebo-controlled trial in Parkinson's patients [6][7]. - In Part 2, the first cohort included 12 patients dosed twice weekly over four weeks, with eight receiving 200 mg of HER-096 and four receiving placebo, leading to the Data and Safety Monitoring Board's recommendation to proceed to the final cohort [6][8]. - The primary objective of the Phase 1b trial is to evaluate the safety, tolerability, and pharmacokinetics of repeated subcutaneous doses of HER-096, along with monitoring symptom progression using MDS-UPDRS and wearable devices [7][8]. Group 2: HER-096 Overview - HER-096 is a first-in-class synthetic peptidomimetic designed to mimic the activity of cerebral dopamine neurotropic factor (CDNF), capable of crossing the blood-brain barrier and allowing for convenient subcutaneous administration [5][11]. - The drug has a multi-modal mechanism of action that may protect against neuronal degeneration and cell death associated with Parkinson's disease, potentially halting disease progression and improving patients' quality of life [5][11]. - The ongoing Phase 1b trial builds on positive results from the Phase 1a trial, which demonstrated a good safety and tolerability profile, as well as effective blood-brain barrier penetration of HER-096 in healthy volunteers [10][12]. Group 3: Funding and Support - The Phase 1b trial is funded by the Michael J. Fox Foundation for Parkinson's Research and Parkinson's UK, indicating strong support from prominent organizations in the field [8][9]. - The trial is being conducted in Turku and Helsinki, Finland, by Clinical Research Services Turku – CRST Oy, showcasing collaboration with established research organizations [9].