The U.S. Food and Drug Administration (FDA) recently stated that there was sufficient evidence of a novel investigational oral beta-secretase cleaving enzyme (BACE) inhibitor E2609 to begin phase III clinical studies.
The inhibitor, made by Eisai Co., can now advance to further studies. The goal is to help patients with early Alzheimer’s disease.
The FDA confirmed the current data package after receiving clinical as well as preclinical data at its Study 202 end-of-phase II meeting. With the information in the package, the FDA advanced the new tool to phase III studies.
The new study protocol will involve patients with early Alzheimer’s disease. There will be a placebo-controlled group who will receive a 50 mg dose of E2609 each day. The primary outcome endpoint will be assessed after 24 months.
“We believe that the phase III clinical study design outline agreed upon will enable us to efficiently conduct studies on BACE inhibitors aimed at realizing preemptive medicine and will accelerate the development of E2609,” Dr. Lynn Kramer, chief medical officer of Eisai Neurology Business Group, said. “We are striving to deliver E2609 to patients around the world as soon as possible and contribute to increasing the benefit for patients.”
