AC0058 – BTK Inhibitor
Preclinical studies demonstrated that AC0058 has the potential to disrupt signaling mediated by tyrosine kinases and may be useful for controlling excessive or aberrant T and B cell activation in autoimmune diseases.
Consequently, AC0058 is being investigated as a targeted therapy for systemic lupus erythematosus (SLE), an autoimmune disease characterized by over-active B cells. It is anticipated that this drug can address the unmet needs of many patients with SLE, for whom there are currently no effective therapies.
>90% BTK occupancy achieved for all doses evaluated in Phase 1 MAD study.
ACEA has successfully completed a Phase 1 clinical trial of AC0058 in 56 healthy volunteers in the U.S. Our compound was found to be safe and well tolerated at all tested doses (50-600 mg total daily dose). Based on the encouraging safety data, robust pharmacodynamic (>90% BTK occupancy), and dose-dependent pharmacokinetic findings, ACEA has initiated a Phase 1b study of AC0058 in SLE patients.
For more information about our completed and ongoing clinical trials, please visit www.clinicaltrials.gov.