Parkinson’s trial to use smartphone technology to track data
Herantis, Indivi collaborate to incorporate digital biomarker platform
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- A Parkinson's disease trial will use smartphone technology to track patient data.
- Herantis Pharma's HER-096 treatment, a CDNF protein, is being tested in Phase 2.
- Digital biomarkers will detect early motor and cognitive changes.
Herantis Pharma will use a system based on smartphone technology to measure symptom changes in a Phase 2 trial testing its Parkinson’s disease treatment HER-096.
Researchers will use Indivi’s digital biomarker platform alongside conventional clinical assessments to help researchers detect early changes in motor and cognitive function in patients treated with HER-096. Indivi’s platform provides functional biomarkers derived from smartphone assessments of movement, balance, cognition, vision, and voice, which may support earlier detection of treatment-related changes compared to conventional measures.
“Digital biomarkers have the potential to significantly improve the sensitivity and efficiency of clinical development in Parkinson’s disease,” Antti Vuolanto, Herantis’ CEO, said in a company press release. “We believe the ability to sensitively detect early treatment-related changes in motor and cognitive function may become an important advantage in evaluating the therapeutic potential of HER-096.”
Parkinson’s disease is caused by the gradual loss of dopaminergic neurons (nerve cells that produce dopamine, a chemical messenger essential for movement).
HER-096 is a lab-made version of cerebral dopamine neurotrophic factor (CDNF), a protein in the blood and cerebrospinal fluid (CSF, the liquid that surrounds the brain and spinal cord), and promotes nerve cell survival and recovery. The treatment, designed to enter the brain after a subcutaneous (under-the-skin) injection, was developed based on results from a Phase 1/2 trial (NCT03295786) showing that CDNF delivery via a brain-implanted device in Parkinson’s patients was well tolerated and reduced disease severity.
Treatment shows promise in trials
HER-096 was tested in a Phase 1 trial (NCT06659562) that enrolled healthy volunteers and Parkinson’s patients. It was found to be generally safe and well tolerated, and to increase CSF CDNF levels above the minimum target range, confirming a dosing schedule of two or three doses per week. Adverse events were mild to moderate in severity and mainly included injection site reactions.
Results also showed that HER-096 affected the levels of biomarkers linked to proteostasis (the cellular processes responsible for protein production, folding, and clearance); mitochondrial function, which involves the cell’s energy-producing centers; and neuroinflammation in Parkinson’s patients. The treatment was administered as 200 mg or 300 mg injections twice weekly for one month.
Based on these results, a twice-weekly dosing regimen with a 300 mg dose was deemed suitable for the future Phase 2 trial.
“The mechanism of action of HER-096 is highly compelling, and we believe our digital biomarker platform is particularly well suited to capturing early symptomatic signals and treatment-related changes with greater sensitivity and precision than conventional assessments,” said Shibeshih Mitiku Belachew, MD, PhD, chief medical officer at Indivi.
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