Olatec Therapeutics has received a grant to commence a Phase II clinical trial of dapansutrile to slow down or stop Parkinson's disease progression.
Cure Parkinson’s granted the award for the trial under its International Linked Clinical Trials (iLCT) programme.
Dapansutrile is an oral inhibitor of nucleotide-binding domain, leucine-rich–containing family, pyrin domain–containing-3 (NLRP3).
It acts on the inflammatory response associated with Parkinson's, representing a new therapeutic approach that could modify the disease's course.
The investigator-initiated, randomised, double-blind, placebo-controlled trial is anticipated to begin in mid-2024, contingent upon finalising all contractual agreements and the receipt of regulatory authorisations.
It aims to enrol 36 subjects with early Parkinson's disease at the John van Geest Centre for Brain Repair at the University of Cambridge’s Department of Clinical Neurosciences in the UK.
The treatment duration is set for six months plus a placebo control, followed by an optional open-label phase of a further six months.
This trial will aid in assessing the potential disease-modifying effect on both motor function and non-motor symptoms.
The Neuroscience Theme of the Cambridge Clinical Trials Unit and the NIHR Cambridge Biomedical Research Centre will support the study.
Cambridge Parkinson's Disease Research Clinic lead Dr Caroline Williams-Gray will act as the trial’s principal investigator.
Dr Gray said: “There is a pressing need for a specific treatment, such as dapansutrile, which targets the most relevant aspects of the immune activation pathway in Parkinson’s, without causing general immunosuppression and leading to unwanted side effects.
“In this trial, we aim to determine dapansutrile’s safety and tolerability in patients with Parkinson’s, and to establish whether treatment with dapansutrile can reduce inflammation in both the brain and periphery in Parkinson’s. We will also investigate whether this results in a positive effect on clinical symptoms and disease progression.”
