Herantis receives approval for Phase Ib clinical trial

Translation: Original comment published in Finnish on 9/4/2024 at 7:28 am EEST.

Herantis announced on Tuesday that its  clinical trial application has been approved. With this news, the company can start a Phase Ib clinical trial with HER-096 in Parkinson's disease. Herantis has previously secured funding for this research from the Michael J. Fox Foundation and the Parkinson's Virtual Biotech program. The secured funding is sufficient for the execution of Phase Ib, i.e. until Q3'25 according to our estimates. Any positive results would help to de-risk the investment and pave the way for future partnership negotiations. Herantis is pursuing a partnership agreement for the next upcoming Phase II efficacy and safety study.

Phase Ib to study the dosing, safety and tolerability of HER-096

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.  The study will also evaluate biomarkers in the Parkinson's patients. Biomarkers are markers measured in blood or other samples that can provide information about which patients will particularly benefit from treatment and how HER-096 works in the body. The recruitment of patients will start after completing Part 1.

Funding in place to implement Phase Ib

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 will finance Herantis' Phase Ib clinical trial and expand biomarker research. The funding received is of a significant size in relation to Herantis' short-term financing needs. 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.