Herantis R&D webinar complemented scientific background and roadmap

Translation: Original published in Finnish on 10/24/2024 at 7:41 am EEST.

Herantis organized a webinar on Wednesday to discuss the base research, clinical trial program and financial status of HER-096. There was no major news that would change the direction of the company, but the event clarified and deepened the plans that were already known. The recently initiated Phase Ib clinical trial will deliver first results this year and is expected to be completed in H2'25. A Phase II study to evaluate the potential efficacy of HER-096 is expected to start in H1'26. For the investment story, the information provided was in line with our forecasts, so there was no need to revise our view on the stock as a result of the webinar.

Company also sees potential for HER-096 to treat new diseases

HER-096 is a drug candidate developed by Herantis for Parkinson's disease and is in Phase Ib clinical trials. The webinar began with a review of the latest research on the mechanism of action of HER-096. According to Herantis, the mechanism of action of HER-096 may not only work in Parkinson's disease, but also in other neurodegenerative diseases such as ALS. In addition, certain metabolic diseases, such as diabetes, share the same molecular mechanisms as Parkinson's disease. HER-096 could therefore also be suitable for indications outside the central nervous system. We believe these comments reflect Herantis' early-stage R&D plans and potential new preclinical programs. At this stage, there is no further information on whether they will be taken into clinical trials.

Clinical program plans and timelines refined

The primary objective of the recently initiated 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, 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. This part should be ready by the end of the year. In Part 2, starting in H1’25, 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. This and the whole phase Ib should be completed in H2'25. 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.

HER-096 to be tested in a Phase II trial starting in 2026

The next exciting step in Herantis' future will come later this year when the company announces the results of the first part of Phase Ib. The results further enhance our understanding of the tolerability and behavior of HER-096 in the body. If all goes well, the second part of the study will be initiated in H1'25 and completed in H2'25. Based on the safety record to date and the funding already secured, we believe a smooth continuation is likely. Preparations for Phase II are underway, but Phase Ib data is needed to finalize the study design. Herantis plans to initiate a Phase II study in H1'26. The duration of the study will depend on a more detailed plan, but the company estimates that it could take roughly 2 years. The duration depends on factors such as the number of patients, the number of hospitals, and the duration of drug administration. The company said it has already held a significant number of discussions regarding a potential partnership agreement to fund further research. The webinar highlighted the need for Phase Ib data, including biomarker data, from the candidate partners in the discussions. In addition, full readiness for the start of Phase II is important. In practice, this means, for example, a ready-made trial plan, a network of hospitals to conduct the trial, and the ability to produce sufficient quantities of the drug. Herantis is seeking a partnership agreement to fund Phase II.