Herantis Pharma Plc announced positive results from its Phase 1a clinical trial in healthy subjects. The clinical trial demonstrated favorable safety and tolerability, fast uptake of HER-096, and significant HER-096 concentrations in the cerebrospinal fluid (CSF) after a single subcutaneous injection. Topline data overview: Overall good safety and tolerability profile in young and older healthy subjects.

As expected, there were mild local injection site adverse events both in the HER-096 and the placebo groups. Plasma pharmacokinetic (PK) profile in humans is well aligned with preclinical data. Maximum plasma concentration reached at the highest dose level (300 mg) was approximately 10 000 ng/ml and the plasma half-life was approximately 2 hours in all dose groups in young subjects and 2.5 hours in older subjects.

Elimination of HER-096 occurred mainly via renal excretion as predicted by preclinical studies. HER-096 concentration in the cerebrospinal fluid (CSF) reached 50 ? 100 ng/ml within 4 ?

12 hours after a 200 mg subcutaneous dose of HER-096. This is in the predicted pharmacologically active CSF concentration range and is aligned with the preclinical data. Based on these very encouraging Phase 1a results, Herantis intends to advance HER-096 into a Phase 1b clinical trial in 2024 with the aim to demonstrate safety and tolerability for multiple subcutaneous dosing of HER-096 in Parkinson?s disease patients, start other preparations for Phase 2 readiness and explore the potential of HER-096 in other indications.

About the HER-096 Phase 1a clinical trial: The Phase 1a trial was a randomized, double-blinded, placebo-controlled, safety, tolerability, and pharmacokinetic trial of subcutaneous single ascending doses of HER-096. In part 1 of the trial, a single subcutaneous dose of HER-096 or placebo was administered to young, healthy, male subjects (20-45 years of age) to assess safety, tolerability, and the pharmacokinetic profile of HER-096 (plasma, urine) in six ascending dose groups, 6 dosed with HER-096 and 2 dosed with placebo in each dose group. In the part 2 of the trial, 12 older healthy subjects (50-75 years of age), both males and females, were administered a single dose of HER-096 to assess safety, tolerability, and the pharmacokinetic profile of HER-096 including blood-brain barrier penetration (plasma, urine, CSF).

In total, the trial recruited 60 healthy volunteer subjects. The trial took place at a single site in Finland and was conducted by the contract research organization Clinical Research Services Turku ? CRST Oy.