September 2024 update

In short

Looking back on more than two years of research, the update said the best dosing schedule is still being studied and that protocols have changed a great deal since 2022. Zhittya described preparing the animal testing needed to file an Investigational New Drug application with the FDA for intranasal FGF-1.

CEO Dan Montano called the September update an "epiphany," meaning a moment of sudden insight about how to judge the Parkinson's research.

Since May 2022, when the first two people with Parkinson's were dosed, the team had focused on two questions: whether FGF-1 caused harm, and how best to use it. Two years and four months later, the update said participants had shown improvements in motor scores, thinking and physical function.

Mr. Montano wrote that he was still frustrated. The team had gone from dosing Level 1 to Protocol 17, which gives almost 40 times more FGF-1 spread over two years, and still had not found the best dosing. "We are making great progress, but we are not where I want us to be," he wrote.

Looking at decline as well as recovery

The insight came from the very first group. Seven volunteers were recruited for the first dosing in May 2022, but only two came. In August 2024, Mr. Montano heard from two of the five who did not take part.

They told him their health had declined sharply over the two years.

One of the two original participants wrote that same month. She was not fully recovered, but by her account she had not declined over the two years. Mr. Montano realized he had been measuring only how close participants were to full recovery. He now thought he should also ask whether FGF-1 had kept them from getting worse.

He was direct about the limits of that comparison. "Do I have empirical evidence to support that statement? No," he wrote, explaining that Zhittya does not keep track of people who did not take part.

The monkey study

What he could point to was a chart from the earlier monkey study, which was done by researchers outside Zhittya. One group of monkeys with an experimental form of Parkinson's received FGF-1 and one group did not. The chart showed the first group improving while the second continued to decline. Mr. Montano saw the two original participants as being on the improving line: better, but not fully recovered.

Next steps

Zhittya was preparing the animal testing needed for FGF-1 given through the nose, so that it could apply to the FDA to begin clinical trials. Mr. Montano hoped to file that application in 2025 and to start a Phase I clinical trial in Parkinson's in the United States in 2026.

The update shared seven messages from participants, sent as many prepared for their next round of dosing. They covered energy, walking, balance, mood, sense of smell, memory and tremor. Some were mixed, describing good days and bad days, or changes that were hard to judge.

Dr. Jack Jacobs wrote about a different subject that month, tinnitus (ringing in the ears), which the team planned to study. He was also due to speak on Parkinson's at Dar Al Shifa Hospital in Kuwait City in early October.

Mr. Montano ended by apologizing for the frustrated tone of the August update. He wrote that the work is "a marathon," and that he needed to notice the small victories along the way.

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