Herantis Pharma Plc announced that it has submitted a Clinical Trial Application (CTA) to the Competent Authority for obtaining authorization to conduct a Phase 1b clinical trial of HER-096 in Finland. The primary aim of this clinical trial is to show that repeated subcutaneous doses of HER-096 are safe and well-tolerated in patients with Parkinson?s disease. The trial also aims to evaluate selected biomarkers, discover and identify novel biomarkers, and to evaluate pharmacokinetic profile supporting dose selection for Phase 2 clinical trial.

The Phase 1b clinical trial will enroll up to 12 healthy volunteer subjects and up to 24 patients with Parkinson?s disease. HER-096 is an engineered peptidomimetic molecule designed to mimic the activity of CDNF, a protein that promotes cell survival and functional recovery of neurons. HER-096 modulates the Unfolded Protein Response (UPR) pathway, the regulation of which is essential in restoring the cell protein balance (proteostasis) and preventing the processes leading to, e.g., cytotoxic protein aggregation and neuronal cell death in the brain.

In addition, HER-096 alleviates inflammation in the affected brain area. 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.