Part 1 of the Herantis trial completed

Translation: Original published in Finnish on 11/12/2024 at 7:16 am EET.

Herantis issued a press release on Monday announcing the completion of the Part 1 of the Phase Ib clinical trial of the drug candidate HER-096 in healthy volunteers. The trial has progressed rapidly, with the first dosing announced less than a month ago. The safety profile and behavior of HER-096 in the body were as expected and in line with previous data. Recruitment of Parkinson's patients to Part 2 of the trial has already started, and things seem to be going according to the company's plans.

Early phase trial to study safety and tolerability

The primary objective of the recently initiated Phase Ib clinical trial 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. According to the press release, both the pharmacokinetic (i.e. how the drug behaves in the body) and safety profiles were as expected and in line with previous data. There were therefore no obstacles to proceeding to Part 2.

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.

Progressing as planned

The Herantis trial appears to have progressed swiftly and completion within the announced timeframe of H2'25 seems likely to us. The results so far also 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.