Herantis’s Parkinson’s Therapy Passes Preliminary Trial Safety Evaluation

An independent review board has found Herantis Pharma’s Parkinson’s therapy safe, paving the way for a Phase 1/2 clinical trial in Sweden to continue.

The board based its decision on the safety results seen in the first few patients treated with cerebral dopamine neurotrophic factor, or CDNF, at Karolinska University Hospital in Stockholm.

Its findings mean Herantis can recruit patients at two other study sites — Helsinki University Hospital in Finland and the Skåne University Hospital in Lund, Sweden. Karolinska University Hospital will continue recruiting patients.

The trial is evaluating the drug’s effectiveness as well as safety.

“Patient safety is always our first priority,” Sigrid Booms, Herantis’ director of clinical development, said in a press release. “Clinical [trial] dosing of CDNF for the first time in the world is a major milestone for our company. We are very pleased with the progress, and the collaboration with the top-level neurological and neurosurgical teams of these three hospitals.”

The company hopes to “have all patients recruited in the study by the end of 2018,” Booms added.

Herantis is developing CDNF as a treatment for neurodegenerative diseases such as Parkinson’s and ALS.

Preclinical-trial studies showed that natural CDNF, a protein found in blood and cerebrospinal fluid, can protect against and restore nerve cell damage.

The findings prompted Herantis to start the Phase 1/2 trial of its formulation of CDNF as a treatment for Parkinson’s (NCT03295786).

The trial’s goals include seeing if CDNF is safe and effective, and if Parkinson’s patients can tolerate it.

Herantis is administering the treatment directly to patients’ brains with a delivery system implanted there. It is taking this approach, it said, because oral or TV-delivered administration would not be effective.

In addition to testing the safety of the treatment itself, Herantis is evaluating the implanted delivery system’s safety and effectiveness. The company will have some previous results to go on. Researchers in another clinical trial reviewed the implant system’s safety in 40 patients.

Two-thirds of the patients in the Phase 1/2 trial are receiving monthly infusions of one of two doses of CDNF for six months. The other third are receiving monthly infusions of a placebo.

After the trial is completed, some patients may be able to receive CDNF in an extension study.