Core Insights - Herantis Pharma has successfully completed a six-month preclinical Good Laboratory Practice (GLP) toxicology study for its lead clinical asset, HER-096, demonstrating a favorable safety and tolerability profile, which supports its advancement towards a Phase 2 clinical efficacy trial [1][2] - The completion of the toxicology study is a significant milestone in the HER-096 program, providing a strong foundation for further clinical development following positive results from the Phase 1b trial [2][3] - HER-096 is a first-in-class small peptide designed to mimic the activity of cerebral dopamine neurotrophic factor (CDNF), with the potential to stop the progression of Parkinson's disease and improve patients' quality of life [5][8] Preclinical and Clinical Development - The preclinical toxicology study results align with previous preclinical and clinical data, reinforcing confidence in HER-096's long-term administration suitability [1][2] - The Phase 1b trial of HER-096 met all primary and secondary endpoints, with pharmacokinetic data consistent with healthy volunteers and confirmed efficient brain penetration [3][4] - Herantis plans to initiate a Phase 2 clinical trial in 2026 to evaluate the efficacy, safety, and tolerability of HER-096 in early-stage Parkinson's patients [4][8] Funding and Support - The completion of the preclinical toxicology program marks the final milestone of the EIC Accelerator Grant project, which provided EUR 2.5 million to support the development of HER-096 and its biomarker program [2][3] - The biomarker development results have already been applied in exploratory analyses within the Phase 1b clinical trial, enhancing the overall research framework [2][3] Mechanism of Action - HER-096 operates through a multimodal mechanism targeting key drivers of neurodegeneration in Parkinson's disease, including modulation of the Unfolded Protein Response (UPR) pathway and reduction of neurotoxic protein aggregation [6][7] - The compound has shown compelling preclinical results, demonstrating its neurorestorative potential and favorable safety profile following subcutaneous administration [7][8]

Herantis Pharma announces positive topline data for HER-096 in Phase 1b trial for people living with Parkinson’s disease Trial meets all primary and secondary endpoints establishing a strong foundation to Phase 2 The clinical trial demonstrated that both repeated 200 mg and 300 mg doses of HER-096 are generally safe and well tolerated in Parkinson’s disease (PD) patients.Results from the clinical trial demonstrated a pharmacokinetic profile consistent with predictions from the single-dose studies in healt ...