Herantis trial progressing as planned

Translation: Original published in Finnish on 5/13/2025 at 7:30 am EEST.

Herantis reported on Tuesday on the progress of the HER-096 Phase Ib clinical trial. The trial has progressed as planned, with results expected in September.

Early phase trial to study safety and tolerability

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. In Part 1, 8 healthy volunteer subjects were administered with a single dose of HER-096. The results showed that both the pharmacokinetic (i.e. how the drug behaves in the body) and safety profiles were as expected and in line with previous data.

In Part 2, 28 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 and the behavior of the drug. The aim of the study is also to evaluate selected biomarkers, and to discover and identify novel treatment response biomarkers in Parkinson’s patients. Biomarkers can help to pre-select patients who may benefit from the treatment and to monitor the efficacy of the treatment. According to the latest update, the first patients in the final cohort have been dosed with HER-096. The trial is therefore progressing as planned, and completion of the results on schedule in September seems likely.

Progression to the next development phase likely

The results reported thus far seem to support the continuation of the clinical program, although more detailed results will probably not be available for evaluation until the completion of Phase Ib. Funding for the current phase has already been secured and the next major threshold in the HER-096 development program will be the transition to and funding of Phase II clinical trials. In our view, funding is the key issue to be resolved for the research pipeline to move forward.