Health Canada has issued a no objection letter in response to IntelGenx’s (TSXV:IGX; OTCQX:IGXT) amended clinical trial application for the ongoing Montelukast VersaFilm Phase 2a (BUENA) clinical trial in patients with mild-to-moderate Alzheimer’s disease (AD).
The amended application was based on additional efficacy testing of montelukast in an AD mouse model, which demonstrated that the treatment effect was dose-dependent, with higher doses of montelukast significantly increasing the mice’s cognition in two behavioral tests.
“We are delighted with Health Canada providing the authorization for IntelGenx to proceed with our amended protocol, which enables us to continue the BUENA trial at an increased daily dose,” Dr. Horst Zerbe, CEO of IntelGenx, said in a statement.
“We are looking forward to continuing enrollment at our Canadian sites under this amended protocol, which is based on preclinical data demonstrating Montelukast VersaFilm’s increased efficacy at higher doses. In addition, we continue to evaluate the trial’s expansion to the U.S. via a potential IND filing with the FDA,” he added.