First Patients Dosed in Final Phase 1b Trial Cohort for HER-096 in Parkinson's

Herantis Pharma Plc has announced the commencement of dosing for the final cohort in its Phase 1b clinical trial of HER-096, a novel treatment for Parkinson’s disease. This innovative therapy is the first of its kind, designed to modify the course of the disease and is administered via a convenient subcutaneous route. The trial's main goal is to evaluate the safety, tolerability, and pharmacokinetics of repeated doses of HER-096. In addition, it aims to investigate selected biomarkers and identify new treatment response indicators, along with monitoring Parkinson’s disease symptoms. The trial is anticipated to deliver topline results by September 2025.

HER-096 stands out as a pioneering synthetic peptidomimetic, created to replicate the effects of cerebral dopamine neurotropic factor (CDNF) protein. It possesses a unique quality of crossing the blood-brain barrier efficiently, which is key to its subcutaneous administration. Its multifaceted mechanism of action offers potential protection against neuronal degeneration, a primary cause of Parkinson’s symptoms. The trial's initial part involved eight healthy volunteers receiving a single subcutaneous dose of 300 mg of HER-096, aimed at assessing its safety and pharmacokinetic profile, with promising results reported in January 2025.

The second part of the Phase 1b clinical trial involves a placebo-controlled, double-blind study with patients diagnosed with Parkinson’s disease. It is structured in two cohorts. The first cohort involved 12 patients, receiving doses twice weekly over a month, with eight patients administered 200 mg of HER-096 and four a placebo. Following a favorable safety review by the Data and Safety Monitoring Board, the trial has moved to the final cohort. In this stage, patients will receive 300 mg of HER-096 or a placebo, administered twice weekly over a four-week duration.

The investigational therapy, HER-096, is engineered to simulate the activity of CDNF, which plays a crucial role in neuronal protection and recovery. It influences the Unfolded Protein Response (UPR) pathway, essential for maintaining cell protein balance and minimizing harmful protein aggregation, thereby preventing neuronal death. Furthermore, HER-096 helps reduce inflammation in affected brain regions and easily crosses the blood-brain barrier, making subcutaneous administration feasible and effective. This combination of actions positions HER-096 as a promising candidate to halt Parkinson’s progression and significantly enhance patient quality of life.

Parkinson’s disease is a debilitating neurological disorder impacting around 10 million individuals globally, with no current cure. Existing treatments mainly target symptoms and can have severe side effects. Herantis Pharma aims to address this gap by developing HER-096, which targets the disease mechanism rather than just alleviating symptoms.

The trial, funded by The Michael J. Fox Foundation for Parkinson’s Research and Parkinson’s UK, is being executed in Finland through Clinical Research Services Turku. This Phase 1b study builds on the success of the earlier Phase 1a trial, which demonstrated that HER-096 is safe, well-tolerated, and successfully penetrates the blood-brain barrier in healthy individuals. The ongoing research is crucial to validate HER-096 as a groundbreaking treatment option for Parkinson’s disease, potentially transforming the therapeutic landscape for millions affected by this challenging condition.