IntelGenx Corp. (TSX:IGX/OTCQB:IGXT) has dosed the first patient in a resumed Phase 2a clinical trial involving an oral film of montelukast for Alzheimer’s disease (AD).
The COVID-19 pandemic previously interrupted the study for more than one year.
In 2019, the company initially announced that the study would enroll roughly 70 individuals with mild-to-moderate AD and test a montelukast buccal film.
The company issued a temporary recruitment hold in the second quarter of 2020 and resumed patient screening in October 2021.
Intelgenx produces oral, oral-topical and transmucosal films as well as transdermal patches.
Previously covered by U.S. Patent No. 5,565,473 that expired in 2012, montelukast (Singulair) from Merck & Co. first won FDA approval in 1998.
A 2017 article published in Open Neurology Journal found that the drug appeared to improve memory in a limited number of patients with cognitive impairment. In addition, prior studies involving animals found montelukast to enhance memory function.
In 2021, an article published in Alzheimer’s Research & Therapy found that leukotriene receptor antagonists (LTRAs), including montelukast and zafirlukast, may hold promise for treating Alzheimer’s disease (AD) pathology. It concluded that the drug class “may be relevant in the progression of AD and that there may be potential benefits of treatments that target the pathway.”
Montelukast is currently indicated for treating asthma, exercise-induced bronchoconstriction and seasonal allergic rhinitis.
In 2020, FDA announced that it was requiring a boxed warning for the drug linked to its potential to cause serious mental health side effects.
The IntelGenx study will investigate the safety, feasibility, tolerability and efficacy of montelukast VersaFilm in patients with mild to moderate Alzheimer’s.
“A significant unmet medical need remains for safe and effective treatments for mild to moderate AD,” said Dr. Ludwig Aigner, a member of IntelGenx’s scientific advisory board. “We believe that Montelukast VersaFilm has the potential to be disease-modifying, and we are excited to have resumed patient dosing in this proof of concept trial.”