Herantis: New research data

Translation: Original comment published in Finnish on 9/20/2024 at 8:42 am EEST.

Herantis issued a press release on Thursday regarding a new scientific paper on the mechanism of action of the neuroprotective protein CDNF. Herantis' candidate HER-096 is based on CDNF, so the information is somewhat applicable to HER-096. The publication will increase our understanding of HER-096 but will not have a direct impact on Herantis or clinical trials.

New study investigates the binding and function of CDNF

HER-096 is a drug candidate developed by Herantis for Parkinson's disease in Phase I clinical trials. The structure of the drug is based on the CDNF protein, which has a protective effect on the nervous system. The study published now describes the binding of the CDNF protein to the GRP78 protein. This binding explains the neuroprotective effect of CDNF and HER-096. HER-096 is designed on the basis of CDNF, so the study has some applicability to HER-096. The study will help strengthen the scientific basis of HER-096 and increase our understanding of how the candidate works. However, clinical trials, which will continue for Herantis later this year with the start of a Phase Ib trial, will play a critical role in the development of the candidate.

Next up: the Phase Ib study

The primary objective of the Phase Ib study is to demonstrate that repeated subcutaneous doses of HER-096 are safe and well tolerated in patients with Parkinson's disease. The study consists of two parts. 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. The site in Turku, Finland will now start recruitment of healthy volunteer study subjects. 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. Herantis recently 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.