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Neurodegenerative Brain Diseases (Montelukast) |
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INDICATED FOR DEGENERATIVE DISEASES OF THE BRAIN
Montelukast VersaFilm® is a unique drug opportunity for the treatment of neurodegenerative diseases of the brain, such as mild cognitive impairment, Alzheimer’s disease and dementia.
IntelGenx is working to re-formulate the drug using VersaFilm®, IntelGenx’s proprietary thin film technology, to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases.
Currently, Montelukast is marketed as Singulair® (Merck & Co.), a once daily tablet for the chronic treatment of asthma and seasonal allergic rhinitis. The drug was first approved by the U.S. Food and Drug Administration in 1997 and has a very good safety profile. Montelukast is a leukotriene receptor antagonist that reduces leukotriene-induced bronchoconstriction, decreasing inflammation.
It is believed that leukotriene signalling also plays a role in brain inflammation, and that montelukast could have a positive impact on inflammatory processes in the brain, improving memory impairment.
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In a recent Phase I study, IntelGenx demonstrated that an oral film formulation of Montelukast is safe and well-tolerated in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the Montelukast tablet, demonstrating a clear advantage of delivering Montelukast via film. IntelGenx's Montelukast VersaFilm® also crosses the blood-brain barrier, an essential feature for treating degenerative brain diseases.
IntelGenx is currently preparing for a Phase 2a proof of concept study to assess the safety, feasibility, tolerability, and efficacy of Montelukast VersaFilm® in patients with mild to moderate Alzheimer's Disease.
IntelGenx plans to establish a strategic partnership for the development and subsequent commercialization of a branded differentiated montelukast film product, Montelukast VersaFilm®
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IntelGenx plans to establish a strategic partnership for the development and subsequent commercialization of a branded differentiated loxapine film product, montelukast VersaFilm®.
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