Inhibikase Reports Phase 1 Risvodetinib Trial Outcomes

Inhibikase Therapeutics, a pharmaceutical company specializing in clinical-stage treatments, has recently reported on the Phase 1 clinical trials of risvodetinib, a promising therapeutic agent for Parkinson's disease and its associated disorders. The study, titled "A Phase I, Randomized, SAD, MAD, and PK Study of Risvodetinib in Older Adults and Parkinson’s Disease," was published in the Journal of Parkinson’s Disease on January 13, 2024, and underscores the potential of risvodetinib in managing this prevalent neurodegenerative condition.

Parkinson's disease is a significant health concern, with over a million individuals affected in the United States. Currently, no treatments are available to slow the disease's progression. However, recent research has implicated the c-Abl kinase as a key player in the disease's development. Dr. Milton Werner, President and CEO of Inhibikase, highlighted the significance of the publication, which showcases the early clinical trials of risvodetinib, the company's lead c-Abl inhibitor.

The Phase 1 trials demonstrated that risvodetinib had a favorable safety profile, being well-tolerated by both older healthy subjects and Parkinson's patients. The study involved 94 healthy volunteers and 14 individuals with Parkinson's disease, with participants receiving varying doses of risvodetinib in single and multiple ascending dose studies. The medication was administered to older participants aged 45 to 70, with doses ranging from 12.5 to 325 mg in the single dose study, and daily doses between 25 and 200 mg for seven days in the multiple dose study. Notably, risvodetinib showed a good safety and tolerability profile, with only 11 adverse events potentially related to the treatment and none of clinical significance.

Pharmacokinetic analysis revealed that the drug's exposure was high relative to other kinase inhibitors, and it was found to cross the blood-brain barrier, indicating its presence in the central nervous system. The study also utilized voluntary lumbar punctures to measure risvodetinib levels in cerebrospinal fluid, further confirming its penetration into the brain.

Inhibikase is currently enrolling patients for its Phase 2 201 Trial, focusing on untreated Parkinson's disease patients. As of January 29, 2024, 32 sites are participating in the trial, with 45 participants enrolled, and 19 having completed the 12-week dosing period. Mild adverse events have been minimal, with only seven mild and one moderate event reported.

Inhibikase Therapeutics is dedicated to developing therapeutics for Parkinson's disease and related disorders, with a primary focus on neurodegeneration. The company's lead program, risvodetinib, targets both brain and extra-brain manifestations of Parkinson's disease, as well as other diseases linked to Abelson Tyrosine Kinases. Inhibikase is also exploring other Parkinson's-related disorders and drug delivery technologies to enhance patient experiences and reduce side effects.

The company's commitment to advancing treatments for Parkinson's disease is evident through its ongoing trials and research initiatives. With the positive results from the Phase 1 trials of risvodetinib, there is optimism for the development of effective disease-modifying therapies for Parkinson's patients in the future.