First Parkinson’s Patient Dosed with IkT-148009 in Phase 1 Trial

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by Marisa Wexler |

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The first Parkinson’s patient has been dosed in a Phase 1 clinical trial that is testing IkT-148009, an investigational oral therapy being developed by Inhibikase Therapeutics to slow or stop disease progression.

“We are pleased to begin dosing patients in our Phase 1b study,” Milton Werner, PhD, Inhibikase‘s president and CEO, said in a press release.

IkT-148009 is a small molecule that works by blocking the activity of Abelson tyrosine kinase, or c-Abl, a protein that has been implicated in the development of Parkinson’s disease.

According to Inhibikase, the activity of this protein is thought to help drive the death and dysfunction of nerve cells that occurs in Parkinson’s. As such, blocking c-Abl may help to restore the functionality of nerve cells in the brain and digestive tract, two major organ systems affected by Parkinson’s.

“This is the first time we will assess our selective c-Abl kinase inhibitor in Parkinson’s patients, which could give us an early look into the potential efficacy of this treatment in slowing or possibly halting disease progression and even partly restoring functional loss in Parkinson’s disease,” Werner said.

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Extended Dosing Improves Safety of IkT-148009, Animal Studies Show

Inhibikase had launched a Phase 1 trial (NCT04350177) earlier this year to test IkT-148009 in older healthy volunteers.

No clinically significant adverse events were reported among the 56 participants in the trial, and pharmacological findings were in line with data from animal studies, suggesting high exposure at doses between 12.5 and 100 mg, according to the company.

The U.S. Food and Drug Administration (FDA) in July cleared Inhibikase to expand the Phase 1 study to include people living with Parkinson’s disease.

This portion of the study is expected to enroll 24 patients, who will be randomly selected to receive IkT-148009 at one of three doses, or a placebo. The trial’s main goal is to assess the medication’s safety, tolerability, and pharmacological properties.

Researchers also will assess the treatment’s effect on cognitive and motor function, as well as the function of the digestive tract and clearance of alpha-synuclein aggregates. Those aggregates, or atypical protein clumps in brain cells, are thought to be a driver of Parkinson’s progression.

Inhibikase recently completed a toxicology study of IkT-148009 in animal models, which showed that the therapy’s safety profile improved the longer the drug was dosed.

After that toxicology data are reviewed by the U.S. Food and Drug Administration, the company plans to begin a Phase 2 clinical trial of the therapy.

“As we look ahead, we anticipate completing this study and advancing into a Phase 2a study in 2022,” Werner said.

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