Herantis clinical trial started as planned
Translation: Original published in Finnish on 10/17/2024 at 7:20 am EEST.
Herantis issued a press release on Wednesday stating that HER-096 dosing has started in the Phase Ib trial. The start is in line with the previously communicated timetable and the trial appears to have begun as planned. We estimate that the study will take approximately one year to complete, and the funding has been secured.
Early phase trial to study safety and tolerability
HER-096 is a drug candidate developed by Herantis for Parkinson's disease in Phase Ib clinical trials. The primary objective of the trial now underway is to demonstrate that repeated subcutaneous doses of HER-096 are safe and well tolerated in patients with Parkinson's disease. The trial has two parts and is being conducted by a contract research organization located in Turku, Finland. In Part 1, up to 12 healthy volunteer subjects will be dosed with a single dose for assessment of pharmacokinetic (how the drug behaves in the body) properties of HER-096. In Part 2, up to 24 patients with Parkinson’s disease will be dosed for 4 week, 2 doses per week with either HER-096 or placebo to study the safety and tolerability of repeated subcutaneous doses of HER-096. In the summer, Herantis announced 3.6 MEUR in research funding from the Michael J. Fox Foundation and the Parkinson's Virtual Biotech program. The research funding is sufficient for the implementation of Phase Ib. In the longer term, we have estimated the funding needs for the HER-096 clinical program at roughly 40-50 MEUR, most of which is yet to be confirmed. Herantis has announced that it is seeking a development and commercialization agreement to fund the research program from Phase II onwards.
Herantis Pharma
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 Figures23/08
| 2023 | 24e | 25e | |
|---|---|---|---|
| Revenue | 0.0 | 0.0 | 0.0 |
| growth-% | 150.00 % | ||
| EBIT (adj.) | 0.2 | -5.3 | -5.0 |
| EBIT-% (adj.) | 3,850.00 % | -52,560.00 % | -49,520.00 % |
| EPS (adj.) | 0.01 | -0.26 | -0.21 |
| Dividend | 0.00 | 0.00 | 0.00 |
| Dividend % | |||
| P/E (adj.) | 114.17 | - | - |
| EV/EBITDA | 165.20 | - | - |
