Herantis' latest analysis reveals HER-096's activity in central nervous system
Summary
- Herantis Pharma's Phase Ib trial results show that the HER-096 drug candidate affects Parkinson's disease-relevant biological pathways in the central nervous system, supporting advancement to Phase II clinical trials.
- The study demonstrated a biological response in patients, with HER-096 impacting pathways like proteostasis, mitochondrial function, and neuroinflammation, consistent with preclinical studies and the drug's expected mechanism of action.
- These findings reinforce previous safety data, confirming HER-096's ability to cross the blood-brain barrier and suggesting a biological effect, though therapeutic effects on Parkinson's disease remain unproven.
- The results aid in planning the Phase II trial and bolster Herantis' partnership negotiations by providing evidence of the drug's mechanism of action.
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Translation: Original published in Finnish on 1/8/2026 at 7:37 am EET.
On Wednesday evening, Herantis Pharma published a press release regarding the biomarker analysis of its Phase Ib trial. According to the results, the HER-096 drug candidate affects Parkinson's disease-relevant biological pathways in the central nervous system. These positive results support advancing drug development to preliminary efficacy studies (Phase II clinical trial), assist in planning the Phase II trial, and contribute to the company's partnership negotiations for financing future research. A briefing on the results will be held today at 12:00 p.m. EET and can be viewed here. For now, we don't expect the results to affect our forecasts since we already considered progress toward the next stage quite likely.
Marker data indicates drug's biological activity in central nervous system
Herantis Pharma announced on Wednesday biomarker results collected in the Phase Ib clinical trial of the HER-096 drug candidate. The randomized, blinded study design showed a biological response in patients with Parkinson's disease. HER-096 caused changes in biological pathways in the central nervous system that are relevant to the disease, such as proteostasis, mitochondrial function and neuroinflammation. According to the company, the findings are consistent with previous preclinical studies and the expected mechanism of action of the drug candidate. The study analyzed more than 2.5 million data points, and the findings were consistent across different analytical methods.
Previous safety data reinforced by results
The newly published results complement the main results of Phase Ib, reported in October 2025, which found that HER-096 was safe and well tolerated. The candidate also crossed the blood-brain barrier, reaching its target in the central nervous system. These new results suggest that the candidate also has a biological effect in the central nervous system. However, based on these results, no conclusions can be drawn yet regarding therapeutic effects on Parkinson's disease. The results are an important step in drug development, as animal model results are rarely directly replicated in humans.
Support for further development and partnership negotiations
The results support Herantis' plans to proceed to a Phase II clinical trial, scheduled to begin in 2026. The results can also be used to plan the next study phase. These latest results may be helpful in ongoing partnership negotiations, as they provide potential pharmaceutical partners with concrete evidence of the drug candidate's mechanism of action.<
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Herantis Pharma Plc is a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease. Herantis’ lead product HER-096 is a small synthetic chemical peptidomimetic molecule developed based on the active site of the CDNF protein. HER-096 combines the mechanism of action of CDNF with subcutaneous administration. The Phase 1a clinical trial demonstrated a good safety and tolerability profile as well as blood-brain barrier penetration of subcutaneously administered HER-096. The shares of Herantis are listed on the Nasdaq First North Growth Market Finland.
Read more on company pageKey Estimate Figures20.11.2025
| 2024 | 25e | 26e | |
|---|---|---|---|
| Revenue | 0.0 | 0.0 | 0.0 |
| growth-% | 150.0 % | ||
| EBIT (adj.) | -5.0 | -5.5 | -5.9 |
| EBIT-% (adj.) | -50,270.0 % | -55,119.0 % | -59,321.2 % |
| EPS (adj.) | -0.25 | -0.25 | -0.25 |
| Dividend | 0.00 | 0.00 | 0.00 |
| Dividend % | |||
| P/E (adj.) | neg. | neg. | neg. |
| EV/EBITDA | neg. | neg. | neg. |
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