Herantis Pharma's HER-096 Shows Biological Activity in Parkinson's Disease Phase 1b Trial
Key Insights
Herantis Pharma (search) announced positive Phase 1b biomarker data for HER-096, demonstrating clear biological response in 24 Parkinson's disease (search) patients treated over four weeks.
The drug candidate modulated key disease-relevant pathways including proteostasis, mitochondrial function, and neuroinflammation, consistent with its expected mechanism of action.
The biomarker findings support progression to a planned Phase 2 efficacy trial in 2026 and provide guidance for dose selection in future studies.
Herantis Pharma (search) Plc announced biomarker data from its Phase 1b trial of HER-096 showing clear evidence of biological response in people with Parkinson's disease (search). The clinical-stage biotechnology company reported that the drug candidate modulated disease-relevant pathways consistent with its expected mechanism of action, supporting continued development toward a planned Phase 2 efficacy trial.
Trial Design and Key Findings
The Phase 1b trial enrolled 24 patients with Parkinson's disease (search) who received twice-weekly dosing of either HER-096 or placebo over a four-week period. The trial's exploratory biomarker program generated and analyzed more than 2.5 million datapoints to assess biological responses to HER-096 in humans.
HER-096 exposure was associated with changes across key disease-related pathways, including proteostasis, mitochondrial function, and neuroinflammation. These findings aligned with the expected mechanism of action and indicated disease-modifying potential, according to the company.
"The Phase 1b biomarker data provide encouraging translational evidence that HER-096 drives biologically meaningful changes in people with Parkinson's disease (search)," said Henri Huttunen, CSO of Herantis Pharma (search). "The coordinated shifts we observed across multiple disease-relevant pathways, including proteostasis, mitochondrial function and neuroinflammation, are consistent with a disease-modifying mechanism and align with our preclinical findings."
Biomarker Analysis Results
Untargeted biomarker analyses identified consistent, treatment-associated shifts in biomarkers linked to proteostasis, mitochondrial function and neuroinflammation – biologically relevant pathways to the Unfolded Protein Response and Parkinson's disease (search) – in response to HER-096 treatment.
The alignment between targeted and untargeted biomarker datasets demonstrated modulation of biological pathways directly relevant to HER-096's mechanism of action, in line with preclinical findings. Consistent findings across different analyses and biological layers strengthened confidence in the therapeutic rationale for HER-096 as development progresses to later-stage clinical trials.
Development Strategy and Next Steps
The biomarker findings support continued development of HER-096 and the planned Phase 2 trial to evaluate clinical efficacy. The data will inform dose selection and refinement of clinical endpoints for subsequent studies, as well as guide prioritization of biomarkers for confirmation in future trials.
"Biomarker evidence supporting the expected mechanism of action of HER-096 in people with Parkinson's disease (search) marks a key development milestone for Herantis," said Antti Vuolanto, CEO of Herantis Pharma (search). "These data de-risk the program for potential partners and investors, support readiness for a planned Phase 2 trial to evaluate clinical efficacy and provide guidance for dose selection."
Herantis plans to advance HER-096 into a Phase 2 clinical trial in 2026 to evaluate efficacy, safety and tolerability in early-stage Parkinson's patients. The biomarker data will be presented at upcoming scientific conferences and submitted for publication in peer-reviewed scientific journals.
About HER-096
HER-096 is a first-in-class small peptide that combines the neuroprotective mechanism of cerebral dopamine neurotrophic factor (CDNF) with the convenience of subcutaneous administration. In the Phase 1b clinical trial, HER-096 was shown to be generally safe and well tolerated in Parkinson's disease (search) patients.
Herantis Pharma (search) is a clinical-stage biotechnology company developing disease-modifying therapies for Parkinson's disease (search), with HER-096 as its lead product candidate. The company is listed on the Nasdaq First North Growth Market Finland.