Herantis Pharma Plc, a clinical-stage company developing disease-modifying therapies to stop the progression of Parkinson’s disease, announces the successful completion of a six-month preclinical Good Laboratory Practice (GLP) toxicology study for its lead clinical asset, HER-096. The study demonstrated a favorable safety and tolerability profile, well aligned with the previous pre-clinical and clinical data. These results provide further confidence in the compound’s suitability for long-term administration and represent another important milestone on the path towards a Phase 2 clinical efficacy trial.
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“The successful completion of this long-term toxicology study marks another important step forward for our HER-096 program”, said Henri Huttunen, CSO of Herantis Pharma. “Together with the positive results from our Phase 1b trial, we now have a comprehensive safety and pharmacokinetic dataset that provides a strong foundation for advancing HER-096 into Phase 2 clinical development. We are excited by the growing body of evidence for HER-096 as a potentially game-changing therapy that could become the first disease-modifying and neurorestorative treatment for Parkinson’s disease.”
The completion of the preclinical toxicology program also marks the final milestone of the EIC Accelerator Grant project, which began in 2023. The grant of EUR 2.5 million also enabled Herantis to advance its biomarker development program, the results of which have already been applied in exploratory biomarker analyses within the Phase 1b clinical trial.
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Herantis recently (October 7, 2025) announced positive topline results from its Phase 1b trial of HER-096 in people living with Parkinson’s disease, with all primary and secondary endpoints met. Importantly, pharmacokinetic data were consistent with those observed in healthy volunteers, and efficient brain penetration was confirmed. Herantis expects to report the Phase 1b biomarker data by mid-January 2026, in advance of the JP Morgan Healthcare Conference week in San Francisco, where the Company’s management will be available for meetings.
Herantis plans to initiate a Phase 2 clinical trial in 2026 to evaluate the efficacy, safety, and tolerability of HER-096 in people with Parkinson’s disease.
About HER-096
Herantis Pharma is developing HER-096, a first-in-class drug candidate with the potential to stop the progression of Parkinson’s disease, repair striatal damage and significantly improve both an individual’s symptoms and quality of life.
HER-096 is a small peptide molecule based on the active site of and designed to mimic the activity of cerebral dopamine neurotrophic factor (CDNF), an endogenous human protein known to promote neuronal cell survival and functional recovery.
HER-096’s multimodal mechanism of action targets key drivers of neurodegeneration in PD by modulation of the Unfolded Protein Response (UPR) pathway, reducing aggregation of the neurotoxic protein α-synuclein, and modulation of neuroinflammation. Combined with its demonstrated brain penetration, this enables HER-096 to protect dopamine neurons from further degeneration and supports their functional restoration.
Herantis has established a strong foundation of evidence in both preclinical and clinical settings. CDNF, has demonstrated robust neuroprotective and neurorestorative effects in preclinical models. In a Phase 1 clinical trial with intracranial CDNF conducted in 17 patients with moderately advanced Parkinson’s disease, encouraging signs of clinical improvements and biological responses were observed. To overcome the need for intracranial delivery required for CDNF, Herantis developed HER-096 that has shown compelling preclinical results, demonstrating the full neurorestorative potential of CDNF. Importantly, brain penetration of HER-096 has been confirmed in Parkinson’s patients at levels comparable to those associated with optimal efficacy in preclinical models, and the compound’s safety profile following subcutaneous administration has proven highly favorable.
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Source- GlobeNewswire
