US-based Zhittya Genesis Medicine Inc, a company advancing a group of drugs that trigger the human body's natural regeneration process, has received official regulatory approval from COFEPRIS, the Mexican governing body, to test its novel biological drug in patients with Parkinson's disease, it was reported on Tuesday.
Zambrano Hospital in Monterrey, Mexico, will be conducting the phase one clinical study.
Three ascending doses of Zhittya's biological drug will be tested in patients with 'mild' to 'moderately severe' Parkinson's disease. There will be no placebo dose administered in this First in Man proof of concept study. While the primary purpose of this first clinical trial is to test for the safety of the drug, readouts on possible improvements in the patient's Parkinson disease symptoms will also be studied.
argenx advances ARGX-119 to registrational study for congenital myasthenic syndromes
hVIVO supports Cidara Therapeutics' positive Phase 2b influenza study results
Sanofi's riliprubart receives orphan drug designation in Japan for CIDP
HUTCHMED gains China approval for ORPATHYS and TAGRISSO combination in lung cancer
Hikma Pharmaceuticals USA announces USD1bn of new US investment
UCB reports positive Phase 3 results for fenfluramine in CDKL5 deficiency disorder