Inhibikase Therapeutics is pausing work on its experimental Parkinson’s disease drug risvodetinib and seeking “strategic options” for the med after it came up short in the efficacy stakes.
The Atlanta-based biotech revealed in a Securities and Exchange Commission filing Wednesday evening that while the drug had hit its safety and tolerability primary endpoint in a midstage test for untreated Parkinson’s patients, it had failed to reach the same goals when it came to efficacy.
While not detailing the data yet, which will come in a “future medical meeting,” the company noted in the filing that when it came to functional assessments of risvodetinib within the trial, the “treatment did not demonstrate an improvement in the top hierarchical efficacy measure … at any dose group versus placebo.”
In practical terms, it means the selective inhibitor of the non-receptor Abelson tyrosine kinase drug failed to help Parkinson’s patients do everyday tasks as defined by the standard Movement Disorder Society Universal Parkinson’s Disease Rating Scale.
Given the lack of efficacy, Inhibikase will “pause further development of risvodetinib” while considering “strategic options” for the program. Shares in the biotech fell nearly 20% in after-hours trading Wednesday.
The drug has endured a bumpy clinical road, with the FDA slapping a clinical hold on risvodetinib, then known as IkT-148009, back in 2022. The hold lasted less than three months before the candidate headed back into the clinic.
With risvodetinib on the back burner, the focus for Inhibikase will now be “on advancing lead program IkT-001Pro,” it added in the filing, which is in studies for pulmonary arterial hypertension.