HUGE!Saint Laurent, Quebec, October 9, 2019 – IntelGenx Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced that an independent Data Safety Monitoring Board (“DSMB”) completed its first interim analysis of the ongoing Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”).
The DSMB reviewed compiled safety data from 25 subjects enrolled in the BUENA trial, 13 of which have completed 26 weeks of daily treatment. The DSMB did not raise any concerns regarding safety and recommended that the trial continue.
“We are pleased with the DSMB’s positive recommendation and are looking forward to continuing this trial based on preclinical data demonstrating Montelukast VersaFilm’s increased efficacy at higher doses,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “As we begin to compile early safety and efficacy data and continue enrollment at our Canadian sites, we also plan to evaluate expanding the trial to the United States with the potential filing of an Investigational New Drug Application with the U.S. Food and Drug Administration.”
Recently, Prof. Dr. Ludwig Aigner’s group at the Paracelsus Medical University in Salzburg conducted additional efficacy testing of Montelukast in an AD mouse model in collaboration with IntelGenx. Overall results demonstrated that the treatment effect was dose-dependent, with higher doses of Montelukast significantly increasing the mice’s cognition in two behavioural tests. Detailed results from this testing will be presented at an upcoming medical conference.
Based on this new preclinical data demonstrating that the efficacy of Montelukast VersaFilm is dose dependent, IntelGenx plans to continue the BUENA clinical trial at an increased daily dose, subject to Health Canada approval.
