Zhittya Offers Webinar About Upcoming Compassionate Use Trial

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Zhittya Genesis Medicine is hosting a webinar next week to provide information about the recently announced “Compassionate Use Clinical Trial” of the company’s lead therapy for Parkinson’s disease.

The webinar is taking place on Tuesday, Feb. 1, at 3 p.m. Pacific time (6 p.m. Eastern). Registration is available online.

“Starting this ‘Compassionate Use Clinical Trial’ 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 for those afflicted by this terrible disease,” Daniel C. Montano, CEO of Zhittya, said in a press release.

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Parkinson’s is caused by the death and dysfunction of dopamine-producing cells in the brain, and according to Zhittya, accumulating evidence in recent years has suggested that this may be driven by abnormalities in blood flow. Blood vessels becoming blocked or leaky could stop these brain cells from getting enough oxygen and nutrients, contributing to disease development and progression.

Zhittya’s lead therapy is a version of fibroblast growth factor 1 (FGF1), a naturally occurring signaling molecule that promotes blood vessel growth around cells that are damaged or oxygen-deprived. Preclinical experiments done in mouse and nonhuman primate models of Parkinson’s have suggested that the experimental treatment could improve motor function.

The therapy also promoted the new growth of dopamine-producing neurons (nerve cells) in the brain. This suggests that the therapy “appears to be affecting the root cause of Parkinson’s disease, namely the loss of these specialized neurons,” according to Zhittya.

“We’ve seen remarkable outcomes in our preclinical animal studies, and we are confident that we’ll see successful results in humans as well,” Montano said.

Zhittya announced the “Compassionate Use Clinical Trial” earlier this month. The trial will be open label, meaning all participants will get the active treatment, with no placebo. The therapy will be administered through the nose, then directly into the brain, using a proprietary device.

The trial’s main goal is to assess the safety profile of the experimental therapy, though efficacy-related measures also will be assessed.

“Over the last two decades, we’ve dedicated tremendous resources to reach the point where we can now officially test our hypothesis that Parkinson’s disease is a disorder caused by issues of micro-vascularization within the brain,” Montano said. “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.”

Individuals interested in participating can submit their information through an online form. Eligible patients will be contacted and sent additional information, including trial site locations and eligibility criteria.

“We are pleased that we are able to start this ‘Compassionate Use Clinical Trial’ as we believe there is an urgent need to test new compounds for this unmet medical need treating the cause of Parkinson’s Disease,” said Jack Jacobs, PhD, president and chief science officer of Zhittya. “Going forward, we hope to seek successful approval of our Parkinson’s disease treatment.”