Herantis Pharma said today its first clinical study of Herantis’ cerebral dopamine neurotrophic factor (CDNF) in Parkinson’s disease, set to start next year, will use Renishaw’s drug delivery system for clinical administration of the protein, through a collaboration whose value was not disclosed.
Herantis said it will contribute jointly with Renishaw to funding the clinical study, with both companies expecting to benefit from the resulting clinical data on CDNF and drug delivery system, respectively.
The two companies are partners in a consortium that has applied for a study-related grant of approximately €6 million ($6.5 million) through the EU’s Horizon 2020 Framework Programme. Clinical trial applications have been submitted to regulatory authorities.
The study’s planned beginning of patient recruitment has been postponed from late this year to the first half of 2017, Herantis said, citing “prolonged” regulatory processes and ongoing EU grant negotiations.
Herantis said the postponement and collaboration with Renishaw will not affect its previously issued guidance to investors. In August, Herantis said it expected to finish 2016 with a “positive” financial position, though it added that it does not expect to generate essential revenue.
CDNF is a Herantis-patented endoplasmic reticulum-located and -secreted protein that according to the company has neuroprotective and neurorestorative properties. Herantis is preparing for a first-in-human clinical study of CDNF in Parkinson’s after a preclinical development program showed CDNF to have efficacy in several models.
CDNF is also in preclinical development program for the treatment of amyotrophic lateral sclerosis (ALS).