The first patient in the Phase 1/2 clinical trial has enrolled at the Karolinska University Hospital in Stockholm. The study will also involve another hospital in Sweden and one in Finland.
Herantis is developing CDNF as a treatment for both Parkinson’s and amyotrophic lateral sclerosis, or ALS.
The work has been occurring at the University of Helsinki in Finland under the leadership of Professor Mart Saarma.
CDNF is based on a protein present in blood and cerebrospinal fluid. Preclinical-trial studies showed that it has neuroprotective and neurorestorative properties in brain cells that generate the neurotransmitter dopamine. This suggests it has the potential to help Parkinson’s patients.
The therapy can’t be delivered as a pill or injection because the body will not transport it to the brain. So in the trial a neurosurgeon will implant a drug delivery system in patients’ brains.
Herantis is seeking 18 patients for the trial. Each will have to make more than 25 visits to a hospital involved in the study over 10-16 months. More information on the trial can be found here.
Some of the patients will receive CDNF and some a placebo. The trial’s main objectives are to assess the therapy’s safety and effectiveness. Participants will also get a chance to participate in an extension study in which all patients will receive CDNF.
In addition to the Karolinska University Hospital in Stockholm, two other study sites – Helsinki University Hospital in Finland, and Lund University Hospital in Sweden – will start recruiting patients as soon as researchers gather safety data from the first site. This should happen during the first quarter of 2018.
“It is highly rewarding to reach this milestone after years of determined effort by our team, and more than a decade of research by professor Mart Saarma’s group at the University of Helsinki,” Sigrid Booms, Herantis’ director of clinical development, said in a press release.