Herantis Pharma Plc announced that the Finnish Medicines Agency, Fimea and the ethics committee have approved the Clinical Trial Application (CTA) submitted in December 2022. The Phase 1 study will be conducted in Finland. The approved study is a randomized, double-blinded, placebo-controlled, safety, tolerability, and pharmacokinetic study of subcutaneous single ascending doses of HER-096 in healthy volunteer subjects.

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.