Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has granted approval for the first in-human clinical trial of Zhittya Genesis Medicine‘s (ZGM)’s investigational therapy for Parkinson’s disease.
Parkinson’s is characterized by the death of dopamine-producing neurons in the brain. A hypothesis that has gained traction in recent years asserts this may be, at least in part, a result of problems with blood flow. Cells in the brain require a lot of oxygen and nutrients to function, so if blood flow is restricted, it could cause these cells to — in essence — starve.
ZGM’s investigational compound is a version of the protein fibroblast growth factor 1 (FGF1). This protein stimulates blood vessel growth (angiogenesis), though critically, it is thought to have this effect only on cells that are already damaged or oxygen-deprived. So, this compound may be able to increase blood flow to the starved cells in the brain, without inducing unintended effects elsewhere in the body.
ZGM previously released preclinical data showing that FGF1 improved motor function and led to the regeneration of dopamine-producing neurons in mice and monkeys with modeled Parkinson’s disease.
This first in-human clinical trial will test three doses of ZGM’s compound in participants with mild-to-moderately-severe Parkinson’s disease. As this is largely a proof-of-concept study, no placebo will be given.
The study’s primary objective is to determine the safety profile of the treatment. Efficacy-related outcomes also will be assessed.
The study will take place at Zambrano Hospital in Monterrey, Mexico.
“Gaining approval to conduct a Phase I clinical trial in Mexico represents another major step for us and our partners in learning whether our medicine is safe in humans and, if so, whether we can modify the progression of Parkinson’s disease to enhance outcomes,” Daniel C. Montano, the CEO of ZGM, said in a press release. “We are entering a true proof of concept trial that will hopefully indicate we can treat and possibly even reverse the effects of Parkinson’s disease. We’ve seen remarkable outcomes in our preclinical animal studies, and we are confident that we’ll see successful results in humans as well,” he 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. Our partners in Monterrey, Mexico have also been outstanding,” added Jack Jacobs, PhD, ZGM’s president and chief scientific officer.
In addition to Parkinson’s, ZGM has stated plans to test its compound in other neurological conditions, including amyotrophic lateral sclerosis (ALS), stroke, and major depressive disorder.