IntelGenx (TSX-V:IGX; OTCQX:IGXT) reported that an independent data safety monitoring board (DSMB) completed its first interim analysis of the company’s ongoing Montelukast VersaFilm Phase 2a clinical trial, called BUENA, in patients with Alzheimer’s disease (AD).
Based on safety data from 25 subjects – 13 of which have completed 26 weeks of daily treatment with Montelukast VersaFilm – the DSMB did not raise any safety concerns and recommended that the trial continue.
Based on recent 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.
“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,” CEO Dr. Horst Zerbe, said in a statement.
“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 IND application with the FDA,” he added.