Inhibikase announces publication Phase 1 studies with risvodetinib

Inhibikase Therapeutics announced a publication of Phase 1 clinical studies with risvodetinib, a potential disease-modifying therapy for Parkinson’s disease and related disorders. The publication entitled “A Phase I, Randomized, SAD, MAD, and PK Study of Risvodetinib in Older Adults and Parkinson’s Disease” was published online in the peer reviewed Journal of Parkinson’s Disease on January 13, 2024. “Parkinson’s disease remains one of the most prevalent neurodegenerative diseases worldwide, affecting more than a million people in the U.S. alone. To date, there are no approved therapies to slow or halt disease progression, however, recently published work by us and our collaborators have pointed to the c-Abl kinase as having an important role in the disease process,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase. “Our publication in the Journal of Parkinson’s Disease highlights our early clinical work with risvo, our lead selective inhibitor of c-Abl. In Phase 1 studies, risvo was shown to have a favorable safety profile that was well tolerated by older or elderly healthy subjects and by patients with Parkinson’s disease. As we look ahead, we are rapidly advancing our 201 Trial in untreated PD patients and look forward to reporting topline results, possibly as early as the second half of 2024 depending on the enrollment date of the last trial participant.” The publication highlights the safety, tolerability and pharmacokinetics of risvo in 94 healthy volunteers and 14 participants with Parkinson’s disease. The multi-part study evaluated risvo in both single ascending dose and multiple ascending dose studies. Risvo demonstrated a favorable safety and tolerability profile following both single or multiple doses across all trial participants. Only 11 of the observed adverse events were deemed possibly treatment-related, with none of clinical significance. Single dose pharmacokinetics were approximately linear between 12.5 mg and 200 mg for both Cmax and AUC0-inf with no pharmacokinetic difference between healthy volunteers and participants with PD. Exposures at each dose were high relative to other drugs in the same kinase inhibitor class. Of note, voluntary lumbar puncture was used to measure the concentration of risvo in cerebrospinal fluid in six participants with or without PD. In these participants, risvo was measured in the cerebrospinal fluid just before dosing on the 7th day, when the concentration of risvo would be at steady-state trough.