Herantis Pharma will conduct a Phase 1-2 clinical trial in Sweden to investigate whether its experimental drug CDNF can help Parkinson’s disease patients.
The announcement came after the Medicines Agency of Sweden authorized the trial.
Recruitment of the 18 patients for the trial will begin in the first half of 2017. The study will start at the Karolinska University Hospital in Stockholm. Two other university hospitals will enroll patients later in the year.
CDNF, or Cerebral Dopamine Neurotrophic Factor, is a proprietary neuroprotective and neurotrophic protein. That means it protects and supports neuron development. Herantis has patented it worldwide to treat Parkinson’s.
“CDNF is a novel neurotrophic and neuroprotective factor, which affects several mechanisms relevant to Parkinson’s disease,” Sigrid Booms, Herantis’ director of clinical development, said in a news release. Based on preclinical trial data, she said, CDNF could become “a significant improvement over currently available treatments. We are really excited to proceed to this first clinical study.”
“Parkinson’s disease is a tremendous financial burden to societies, in addition to the human suffering,” Pekka Simula, Herantis’ CEO, said. “Known drugs only alleviate motor symptoms until further disease progression. Our ambition is to slow down, stop, hopefully even reverse the progression of the disease. CDNF is a promising novel drug candidate which works via several relevant biological mechanisms that also clearly differentiate it from conventional neurotrophic factors. This regulatory approval marks a very important milestone in our development.”
Parkinson’s is caused by genetic mutations that alter the normal functioning of the brain. This leads to the slow, progressive death of dopaminergic neurons in a brain region called the substantia nigra, which is involved in movement control.
Dopamine is a signaling molecule that travels between areas of the brain that control voluntary movement, such as eating and writing. Loss of dopaminergic neurons underlies the most common symptoms in Parkinson’s such as tremors, rigidity and movement problems.
Motor symptoms can be managed with medication, but no treatment is available to halt the disease’s progression. Advanced stages of the disease are harder to manage with medication. This leads to patients experiencing walking difficulties, muscle stiffness and tremors. They affect posture and balance and a patient’s ability to perform daily activities.