Finnish biotechnology company Herantis Pharma has begun enrolling healthy volunteers in the second part of its Phase Ia clinical study of HER-096, a drug that has the potential to stop the progression of Parkinson’s disease.
The placebo-controlled, double-blind study is designed to assess the pharmacokinetics, tolerability and safety of single ascending doses of HER-096 in healthy patients.
It intends to enrol up to 60 healthy volunteers. In this part, 12-16 older and elderly healthy volunteers will receive a single dose of HER-096 subcutaneously.
HER-096’s blood-brain-barrier penetration capability HER-096 will also be assessed in the treatment period.
The study will be carried out in Turku, Finland, by contract research organisation CRST.
A peptidomimetic molecule, HER-096 retains the biological activity of the neuroprotective CDNF protein to improve the functionality of damaged neurons.
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The medicine’s ability to penetrate the blood-brain barrier has been proven in preclinical studies, allowing more convenient subcutaneous dosing.
Preclinical models have also demonstrated HER-096’s potential to have a multimodal mechanism of action that mimics CDNF.
This could improve patients’ quality of life and stop the progression of Parkinson’s disease.
Top-line data from the Phase Ia trial are expected by the end of this year.
A slowly progressing movement disorder, Parkinson’s disease is accompanied by symptoms such as difficulty in speech, tremors, muscle stiffness and a general slowing in movement.
Based in Espoo, Herantis Pharma is a clinical-stage biotechnology company that develops disease-modifying therapies for Parkinson’s disease.
The investigational medicinal product HER-096 is the company’s lead product.
In May this year, Inhibikase Therapeutics began dosing patients in a Phase II clinical trial of IkT-148009 for the treatment of Parkinson’s disease.
The double-blind study will randomise patients at a 1:1:1:1 ratio to receive either 50mg, 100mg or 200 mg of IkT-148009 against placebo once a day for 12 weeks.