IntelGenx (TSX:IGX; OTCQB:IGXT) completed patient enrollment in the ongoing Montelukast VersaFilm Phase 2a BUENA clinical trial in patients with mild-to-moderate Alzheimer’s disease (AD).
The company successfully enrolled 52 patients in the study, 18 fewer than initially planned, in a study design modification that received a “no objection letter” from Health Canada. The no objection letter authorized IntelGenx to proceed with the study changes.
IntelGenx, in consultation with its statistical consultant, Cogstate, determined that adjusting the p-value, which determines whether a drug effect exists, to p<0.1 will provide a basis for determining the extent to which the size of the drug effect of 0.6 or greater are statistically significant.
“While there have been exciting recent advancements in the treatment of AD, there is no question that significant unmet medical need remains in this large and growing patient population,” Dwight Gorham, IntelGenx’s CEO, said in a statement.
“As the COVID-19 pandemic effectively halted the BUENA trial’s recruitment for approximately 18 months, followed by imposed post-pandemic restrictions from hospitals, our rationale behind decreasing study enrollment was to avoid any further delay in achieving the program’s goal,” he said.
“We are confident that this Health Canada-authorized study design modification will enable us to utilize data from fewer patients while optimizing the power of the study to detect the effects of Montelukast VersaFilm, compared with placebo.”
IntelGenx expects to complete the BUENA trial in the first quarter of 2024 and report initial trial results the following quarter.
GlobalData recently reported that the AD market is expected to reach $13.7- billion in 2030 across the eight major markets of the U.S., France, Germany, Italy, Spain, U.K., Japan, and China, representing a compound annual growth rate of 20.0% from $2.2-billion in 2020.
