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First healthy volunteers dosed in Herantis’ part 2 Phase 1a study

Herantis Pharma has announced 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.

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.”

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.

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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.

Photo: iStock