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.