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Herantis Pharma (HRNTS) investor relations material
Herantis Pharma Study Result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study background and objectives
HER-096 is a small peptide designed to halt Parkinson's progression by mimicking CDNF and protecting dopamine neurons.
The study included 24 Parkinson's patients, with placebo and two HER-096 dose groups, receiving treatment twice weekly for four weeks.
Phase 1b focused on demonstrating biological response and target pathway engagement in humans.
Over 2.5 million biomarker data points were analyzed to assess biological effects through exploratory assessments.
Biomarker data are intended to de-risk and inform Phase 2 efficacy trials.
Key findings and data interpretation
HER-096 induced broad, dose-dependent proteomic changes in plasma, especially at 300 mg.
Biomarker shifts were observed in proteostasis, mitochondrial function, and neuroinflammation, consistent with the expected mechanism of action.
Targeted assays showed improved glutathione redox balance and reduced mitochondrial DNA lesions, indicating enhanced oxidative stress defense and mitochondrial benefit.
Concordant changes were observed in cerebrospinal fluid and nervous system-derived extracellular vesicles, supporting central and systemic effects.
Consistent, multi-layered data analysis increased confidence in the observed biological shifts and supports the disease-modifying potential of HER-096.
Implications for clinical development
Biomarker data provide proof of biology, bridging preclinical and clinical findings.
Results support dose selection (notably 300 mg) and inform exposure-response relationships and clinical endpoints for Phase 2.
Findings are expected to facilitate partnering and investor discussions for Phase 2 resourcing.
Mitochondrial markers and proteostasis changes are particularly relevant to Parkinson's pathology.
The data are seen as a major milestone, significantly reducing risk for further clinical development.
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