Nordic Life Science 1
DRUG DEVELOPMENT IN THE NORDIC REGION PH A SE I -
I I The company’s ongoing Phase I-II clinical trial examines the neuroprotective factor and novel drug candidate, CDNF, in patients with Parkinson’s disease. THE FIRST PART of the study, in which patients first received a surgically implanted dose delivery system provided by Renishaw, followed by repeated and increased CDNF or placebo dosing for 6 months, met its primary endpoint of safety and tolerability. The recorded Serious Adverse Events (SAEs) were considered by the treating physicians to be unlikely to be related to CDNF and the affected patients fully recovered. Certain SAEs were considered to be probably related to device surgery and the drug administration process. The surgical and infusion procedures were therefore improved. The secondary and exploratory endpoints of the study are to evaluate initial signs of efficacy, including assessments based on the Unified Parkinson’s Disease Rating Scale (UPDRS), dopamine transporter PET imaging, actigraphy measurements and alpha-synuclein levels. The company has observed promising signals in some patients, for instance in dopamine transporter PET imaging, which is an indirect measure of the dopaminergic function. The company will continue to assess the results through the extension part of the study.