FGF-1 improves blood flow, motor function in Parkinson’s patient
Naturally occurring molecule promotes blood vessel growth
Six months of treatment with intranasal FGF-1, a naturally occurring molecule that promotes blood vessel growth, improved blood flow in a brain region profoundly affected by Parkinson’s disease, along with motor function, in the first patient to undergo both assessments.
That’s according to a press release by Zhittya Genesis Medicine, the therapy’s developer, that noted more than 200 patients have been treated with FGF-1 so far in medical studies, with motor skill improvements detected after six months.
“Seeing these kinds of results is nothing short of revolutionary,” Jack Jacobs, PhD, president and chief science officer at Zhittya, said. “For decades, we’ve been confined to symptom management in Parkinson’s care. Now, for the first time, we’re witnessing a treatment that has the potential to target the root cause — restoring blood flow to the brain and giving neurons the nutrients they need to survive and even regenerate.”
In a company update, Zhittya announced that the patient will perform additional brain scans 12 and 18 months after the first one that was conducted before treatment. Six-month data on brain blood flow and motor skills from at least three other FGF-1-treated patients are expected in the near future.
Parkinson’s is a neurodegenerative disease marked by the progressive loss of dopaminergic neurons, nerve cells that produce the signaling molecule dopamine, in a region called the substantia nigra.
The disease has been associated with reduced blood flow in the substantia nigra and Zhittya believes this disruption limits the amount of oxygen and nutrients that reach dopaminergic neurons, contributing to their death. Therefore, stimulating blood vessel growth in the brain could reestablish blood flow and contribute to reducing or even reversing disease progression.
What does intranasal FGF-1 do in Parkinson’s disease?
Zhittya’s experimental therapy is a proprietary version of the FGF-1 protein, which boosts the growth of new blood vessels, that’s administered through the nose to better reach the brain.
Preclinical studies showed it led to a regeneration of dopaminergic neurons and improved motor function in mouse and monkey models of Parkinson’s.
Zhittya previously opened a Phase 1 clinical trial (NCT05493462) to assess the safety, tolerability, and efficacy of two escalating doses of intranasal FGF-1 in the Bahamas in 2022. Its status is unclear.
According to the company, as of Feb. 17, more than 200 people with Parkinson’s have enrolled in its ongoing intranasal FGF-1 study, extending over 2.5 years. On average, treated patients saw a 54% improvement in motor function within six months.
Changes in substantia nigra’s blood flow are being assessed in some patients using functional magnetic resonance imaging (fMRI). Scans before and after treatment are being conducted in collaboration with researchers at Washington University School of Medicine in St. Louis.
Data from the first treated patient to undergo fMRI scans before intranasal FGF-1 treatment and after six months of treatment showed a 21% increase in blood flow. The changes were accompanied by a 50% improvement in motor function, as assessed by standardized clinical tests, according to Zhittya.
“Restoring blood flow isn’t just about improving symptoms,” Jacobs said. “It’s about preventing neuron death and possibly regenerating what’s been lost. We’re at the cusp of a paradigm shift in how we treat not just Parkinson’s, but a host of neurodegenerative diseases.”
The company is also developing FGF-based therapies for other conditions, including stroke, dementia, autism, heart disease, and diabetes.
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