Pharmacokinetic data provides important information about the dose levels and potential dosing intervals in further studies.
The first subject with Parkinson’s disease has been dosed in the Part 2 of the Phase 1b clinical trial of HER-096.
January 28, 2025 I Herantis Pharma Plc (“Herantis”), a company developing disease-modifying therapies for Parkinson’s disease, is pleased to announce an update of the ongoing Phase 1b clinical trial of HER-096:
Analysis of the Part 1 of the Phase 1b study provides significant 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.
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 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.
The study takes place in Turku and Helsinki, Finland conducted by the contract research organization Clinical Research Services Turku – CRST Oy.
More information about participation into the study can be found on the website:
HER-096 is an engineered peptidomimetic molecule designed to mimic the activity of CDNF, a protein that promotes cell survival and functional recovery of neurons. HER-096 modulates the Unfolded Protein Response (UPR) pathway, the regulation of which is essential in restoring the cell protein balance (proteostasis) and preventing the processes leading to, e.g., cytotoxic protein aggregation and neuronal cell death in the brain. In addition, HER-096 alleviates inflammation in the affected brain area. Thanks to its multimodal mechanism of action, Herantis’ HER-096 has the potential to stop the progression of Parkinson’s disease and significantly improve patients’ quality of life.
About Herantis Pharma Plc
Herantis Pharma Plc is a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease. Herantis’ lead product HER-096, is an advanced small synthetic chemical peptidomimetic molecule developed based on the active site of the CDNF protein. It combines the compelling mechanism of action of CDNF with the convenience of subcutaneous administration. The primary aim of the ongoing Phase 1b clinical trial is to show that repeated subcutaneous doses of HER-096 are safe and well-tolerated in patients with Parkinson’s disease. The Phase 1a clinical trial, completed in late 2023, demonstrated a good safety and tolerability profile, and efficient blood-brain barrier penetration of subcutaneously administered HER-096 in healthy volunteers.
Herantis are listed on the Nasdaq First North Growth Market Finland.
Pharmacokinetic data provides important information about the dose levels and potential dosing intervals in further studies.
The first subject with Parkinson’s disease has been dosed in the Part 2 of the Phase 1b clinical trial of HER-096.
January 28, 2025 I Herantis Pharma Plc (“Herantis”), a company developing disease-modifying therapies for Parkinson’s disease, is pleased to announce an update of the ongoing Phase 1b clinical trial of HER-096:
Analysis of the Part 1 of the Phase 1b study provides significant 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.
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 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.
The study takes place in Turku and Helsinki, Finland conducted by the contract research organization Clinical Research Services Turku – CRST Oy.
More information about participation into the study can be found on the website:
HER-096 is an engineered peptidomimetic molecule designed to mimic the activity of CDNF, a protein that promotes cell survival and functional recovery of neurons. HER-096 modulates the Unfolded Protein Response (UPR) pathway, the regulation of which is essential in restoring the cell protein balance (proteostasis) and preventing the processes leading to, e.g., cytotoxic protein aggregation and neuronal cell death in the brain. In addition, HER-096 alleviates inflammation in the affected brain area. Thanks to its multimodal mechanism of action, Herantis’ HER-096 has the potential to stop the progression of Parkinson’s disease and significantly improve patients’ quality of life.
About Herantis Pharma Plc
Herantis Pharma Plc is a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease. Herantis’ lead product HER-096, is an advanced small synthetic chemical peptidomimetic molecule developed based on the active site of the CDNF protein. It combines the compelling mechanism of action of CDNF with the convenience of subcutaneous administration. The primary aim of the ongoing Phase 1b clinical trial is to show that repeated subcutaneous doses of HER-096 are safe and well-tolerated in patients with Parkinson’s disease. The Phase 1a clinical trial, completed in late 2023, demonstrated a good safety and tolerability profile, and efficient blood-brain barrier penetration of subcutaneously administered HER-096 in healthy volunteers.
Herantis are listed on the Nasdaq First North Growth Market Finland.
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