Analysis of the Part 1 of the Phase 1b study provides new information about the pharmacokinetic (PK) profile of HER-096. In the Part 1 of the Phase 1b study eight healthy subjects received a single 300 mg subcutaneous dose of HER-096. PK profile in cerebrospinal fluid (CSF) demonstrates that with 300 mg single dose, the HER-096 concentration in CSF clearly exceeds the minimum target range of 50 – 100 ng/ml that was set for HER-096 CSF exposure based on the preclinical studies.

The data also shows extended CSF exposure compared to plasma in humans confirming the expected HER-096 dosing interval of 2 or 3 subcutaneous doses per week, describes the company.

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First subject with Parkinson’s dosed in Phase 1b trial

Herantis Pharma has also announced that study drug administrations in the Part 2 of the ongoing Phase 1b clinical trial of HER-096 with subjects diagnosed with Parkinson’s disease have started.

The Phase 1b clinical trial, Part 2, is a randomized, double-blind, placebo-controlled trial. There are two dose cohorts in the Part 2, 200 mg and 300 mg of HER-096. In each cohort, 12 subjects diagnosed with Parkinson’s disease will be randomized in a 2:1 ratio to HER-096 or placebo group. The trial consists of a screening period, dosing period of four weeks (2 subcutaneous doses per week), and a follow-up period of 4 weeks. The main objective is to study the safety, tolerability and pharmacokinetics of repeated subcutaneous doses of HER-096.

The study takes place in Turku and Helsinki, Finland, conducted by the contract research organization Clinical Research Services Turku – CRST Oy.

The aim is also to evaluate selected biomarkers, and to discover and identify novel treatment response biomarkers in Parkinson’s patients. Symptoms associated with Parkinson’s will be monitored using both Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and with a wearable recording device.

Topline data is expected in Q3 2025, according to the company’s press release.

The study takes place in Turku and Helsinki, Finland, conducted by the contract research organization Clinical Research Services Turku – CRST Oy.