Kancera AB (publ) reported that the Finnish regulatory agency (FIMEA) has approved Kancera's application to conduct a phase I study of KAND145, the company's second generation fractalkine blocking candidate drug. The application has been submitted through the new centralized EMA process for clinical studies that became mandatory on February 1, 2023. Kancera will now start enrollment of subjects and expect to present top line study results in the second quarter of 2024.

The study is a randomized, double-blind and placebo-controlled phase I study in healthy subjects to evaluate safety, tolerability, pharmacokinetics and food effect after oral single and multiple ascending dosing of KAND145 and interaction with other pharmaceutical products after multiple ascending dosing. The study will be conducted at two sites in Finland and approximately 50 study subjects in total are expected to be enrolled.