Herantis Pharma (HRNTS) Study Result summary

Study background and objectives

• HER-096 is a subcutaneously administered mimic of CDNF, aiming to be the first disease-modifying and neurorestorative treatment for Parkinson's disease.

• The phase 1b trial evaluated HER-096 in Parkinson's disease patients, focusing on safety, tolerability, and pharmacokinetics, following promising preclinical and phase I-A data.

• The study included elderly healthy volunteers (part one) and early-stage Parkinson's patients (part two).

• Inclusion criteria ensured early idiopathic Parkinson's with confirmed dopaminergic deficit and stable medication.

• The study was conducted at two sites in Finland, funded by The Michael J. Fox Foundation and Parkinson's UK, and completed within timeline and budget.

Study design and patient characteristics

• Part one: single 300 mg dose in elderly healthy volunteers to assess safety and PK.

• Part two: 24 Parkinson's patients randomized to 200 mg or 300 mg HER-096 or placebo, two injections per week for four weeks.

• Cohorts balanced in age, sex, BMI, disease stage, and medication use.

• Disease duration and symptom severity were similar across groups.

• All patients used 1–3 symptomatic medications; beta blockers were used for tremor control in some cases.

Safety and tolerability results

• No serious adverse events related to HER-096; one unrelated SAE occurred in placebo.

• Most adverse events were mild, transient injection site reactions; systemic AEs were rare.

• No clinically significant lab, MRI, or hematology abnormalities observed.

• No evidence of antidrug antibody formation in HER-096 recipients.

• All participants completed the study without disruptions.