Herantis Pharma Plc: First healthy volunteers dosed in the part 2 of the HER-096 Phase 1a clinical study

Herantis Pharma Plc | Press Release | August 22, 2023 at 10:30:00 EEST

Herantis Pharma Plc
Press release, 22 August 2023 at 10:30 a.m. EEST

Herantis Pharma Plc (“Herantis”), a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease, announces that the dosing of the healthy volunteers in part 2 of the Phase 1a clinical study has been started based on decision from the Data and Safety Monitoring Board.
Top-line data of the Phase 1a clinical study is expected in Q4 2023.
About the HER-096 Phase 1a clinical study:
Phase 1a is a randomized, double-blinded, placebo-controlled, safety, tolerability, and pharmacokinetic study of subcutaneous single ascending doses of HER-096. In part 1 of the study, HER-096 or placebo was administered to young healthy volunteers and in the now started part 2 of the study, 12-16 elderly healthy volunteers, both males and females, will be administered with a single dose of HER-096 to evaluate the blood-brain-barrier penetration of HER-096. In total, the study aims to recruit around 60 healthy volunteer subjects.

The study takes place in Turku, Finland conducted by the contract research organization CRST.

Link to ClinicalTrials.gov for more information about the study:

More information about participation into the study can be found on the website (only in Finnish):
About HER-096
HER-096 is a peptidomimetic molecule designed to retain the biological activity of the neuroprotective CDNF protein. HER-096 has demonstrated to have a multimodal mechanism of action mimicking CDNF and to improve functional recovery of damaged neurons in preclinical models. Importantly, HER-096 has been shown to readily penetrate the blood-brain barrier in preclinical studies allowing convenient subcutaneous dosing. Thanks to its multimodal mechanism of action, Herantis’ HER-096 has the potential to stop the progression of Parkinson’s disease and significantly improve patients’ quality of life.