The Parkinson’s disease project under development by Finland's Herantis Pharma inched forward this week, with the first part of a tiny first-in-human phase I/II study deemed a hit on safety and tolerability, its primary endpoint. This was despite serious adverse events that were considered “probably” related to the surgery and drug administration process; the therapy consists of a system that administers cerebral dopamine neurotrophic factor, which is surgically implanted in the brain. Herantis said the surgical and infusion procedures had been improved to avoid any such future incidents, adding that there were “promising signals” seen in some patients in dopamine transporter PET imaging. Readouts on secondary and exploratory endpoints, covering CDNF’s efficacy, are expected in the third quarter. These data could also give early hints of whether there is anything to the theory that inhibiting α-synuclein can affect Parkinson’s progression, a crucial point for many other potentially disease-modifying approaches currently in the clinic. The group is planning a phase II study with a longer treatment period – CDNF was dosed for six months in the phase I/II – in earlier-stage Parkinson’s, to begin in 2021.
|Herantis Pharma’s pipeline|
|Phase II||CDNF Parkinson’s project||Dopaminergic neuron stimulant||Parkinson’s disease|
|Phase II||Lymfactin||Vascular endothelial growth factor receptor C gene therapy||Breast cancer-associated secondary lymphoedema|
|Preclinical||CDNF Neurodegenerative Project||Unknown||Neurodegenerative diseases|
|Source: EvaluatePharma, company website.|