May 2024 update

In short

Zhittya marked two years of Parkinson's research studies, with more than 150 people dosed. The update reported the first brain scan measuring blood flow in a study participant with Parkinson's.

The May update led with a first for the Parkinson's research: a brain scan taken before dosing, to be compared with later scans.

The first brain scan

On May 6, 2024, the first participant with Parkinson's had an MRI scan at Washington University in St. Louis to measure blood flow in his brain. The main interest was the area in and around the substantia nigra, which holds the nerve cells that make dopamine. Zhittya's hypothesis is that too little blood reaches this area, leaving those cells short of oxygen and nutrients, so that they work poorly, go dormant or die.

The participant was due to begin FGF-1 dosing on May 17. A second scan was planned at six months and a third at 12 months. CEO Dan Montano wrote that if the later images showed more blood flow to the substantia nigra, that would be evidence to help explain the changes in motor skills participants had reported. Zhittya planned to scan 14 more people, mostly people with Parkinson's.

The update recalled an earlier monkey study, done by researchers outside Zhittya. In it, monkeys with an experimental form of Parkinson's developed new dopamine-producing nerve cells six to eight months after FGF-1 was introduced into their brains.

It also said that most participants with Parkinson's had reported changes beyond movement after taking FGF-1. These included clearer thinking, less brain fog, better balance, a returning sense of smell and taste, and better memory.

Reported headaches

Mr. Montano wrote that dosing began at a very low level and was raised slowly over 24 months to the current Protocol 17. He wrote that about 5% of participants reported mild headaches after dosing, lasting from minutes to a few hours. He was not sure these were related to FGF-1, since many people with Parkinson's have frequent headaches. "We will report everything we know," he wrote.

A first dose by spinal tap

The update described one participant with multiple system atrophy, a different and very aggressive neurological condition. He first received FGF-1 by nasal spray in November 2022. In November 2023 he received it by epidural, but little seemed to reach the fluid around the brain, and no meaningful improvement was seen after six months.

In April 2024 he agreed to receive FGF-1 by spinal tap, directly into the cerebrospinal fluid. Whether it would help him was not yet known, and the team planned to keep monitoring. Mr. Montano wrote that this route might be considered for very advanced neurological conditions.

Two years of dosing

May 2024 marked two years since the first two people with Parkinson's were dosed. Over that time the team improved the delivery device, raised the dose from Level 1 to Level 17, and added repeat dosing at six-month intervals. More than 150 participants had now received FGF-1.

Mr. Montano wrote that participants had reported improvements in motor skills, memory, balance and thinking. He added that the work was still at an early stage. The team did not yet know the best dose or how long dosing should last, and expected the answer to differ from person to person.

Dr. Jack Jacobs wrote about visiting Washington University, where he had studied molecular biology. He recalled that the FGF-1 molecule was first purified more than 40 years ago in the laboratory where he worked.

Two participants' comments were shared, on drooling, brain fog, tremor, sleep and walking. The rest of the update covered other research areas, a conference and government relations.

This summary covers the Parkinson's research in the May 2024 update. The complete update, including the other topics it covered, is below.