Zhittya Genesis Medicine has secured regulatory approval from Mexico’s governing body COFEPRIS to test its drug in people with Parkinson’s disease (PD).
The first phase of the clinical trial will be held at the Zambrano Hospital in Monterrey, Mexico.
Through preclinical studies, the drug earlier indicated its ability to halt and even reverse the decline in motor symptoms in patients.
The trial will see three ascending doses of the drug being tested in subjects with ‘mild’ to ‘moderately severe’ Parkinson’s disease.
There will be no placebo dose administered in this first-in-man proof-of-concept study.
Zhittya’s drug has indicated the ability to arrest the decline and boost the motor skills of the animals tested in preclinical studies on rodents and primates.
Regeneration of newly formed dopamine-producing neurons was also seen in the treated animals, indicating that the drug seems to be impacting the root cause of Parkinson’s disease, the loss of these specialised neurons.
Although the primary aim of this trial is to test for the safety of the drug, it will also study any improvements in the patient’s Parkinson disease symptoms.
Zhittya Genesis Medicine president and chief science officer Dr Jack Jacobs said: “We are pleased that the Mexican regulatory authorities appreciated the urgent need to test new compounds for this unmet medical need and gave us swift approval to initiate our clinical studies in subjects with Parkinson’s disease.”
Jacobs further added: “Going forward, based on the successful approval of our Parkinson’s disease clinical trial process, we also have an application to approve testing of our drug in subjects suffering from amyotrophic lateral sclerosis (ALS), which is currently in the final stages of review at COFEPRIS.”
The firm also plans to file applications to test its drug in patients with chronic stroke and major depressive disorder.