IntelGenx Receives Health Canada Clearance to Begin Phase 2a Study with Montelukast Versafilm(TM) in Mild to Moderate Alzheimer’s Disease
SAINT-LAURENT, QUEBEC–(Marketwired – Dec. 15, 2017) - IntelGenx Corp. (TSX VENTURE:IGX)(OTCQX:IGXT) (the “Company” or “IntelGenx”) is pleased to announce that Health Canada has cleared the clinical trial application for its Montelukast VersaFilm™ intended for the treatment of mild to moderate Alzheimer’s disease (“AD”). The phase 2a proof of concept (“POC”) clinical study will start screening AD patients in Q1 2018.
This randomized, double-blind, placebo controlled Phase 2a POC study will enroll approximately 70 subjects with mild to moderate AD across eight Canadian research sites. The primary study objectives will be to evaluate the safety, feasibility, tolerability, and efficacy of Montelukast buccal film following daily dosing for 26 weeks.
“There are limited treatments available for AD and, of those that are approved, none are disease modifying,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “A recent paper published in the journal, Immunity & Aging, noted that Montelukast has been shown to rejuvenate aged brains in an animal model and suggested that this leukotriene receptor antagonist may have a similar effect in humans. We are very excited to commence this trial and evaluate the potential of Montelukast as a much-needed treatment for AD patients.”
IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. Montelukast has been approved by the U.S. Food and Drug Administration in 1997 for the treatment of asthma and seasonal allergic rhinitis. IntelGenx’ proprietary VersaFilm™ technology is especially suited for special needs patient populations, and the Montelukast VersaFilm™ product therefore offers many distinct advantages over tablets for AD patients, including the avoidance and minimization of first-pass-effects, ease of administration, improved API bioavailability, lower dosing and toxicity, better acceptability and improved compliance.
In a recent Phase I study, IntelGenx demonstrated that an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the regular Montelukast tablet, demonstrating a clear advantage of delivering Montelukast via film. IntelGenx’ oral film also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases.
About Montelukast VersaFilm™:
Montelukast is a leukotriene receptor antagonist used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. Montelukast is a CysLT1antagonist; it blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. This reduces the bronchoconstriction otherwise caused by the leukotriene and results in less inflammation. IntelGenx’ Montelukast buccal film offers a distinct dosage form that improves bioavailability and removes the need for water intake. The latest formulation successfully demonstrated enhanced bioavailability as compared with the brand tablet in a pilot study.
Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform.
IntelGenx’ highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’ state-of-the-art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to its clients. More information about the company can be found at www.intelgenx.com.
This document may contain forward-looking information about IntelGenx’ operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’ plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’ actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’ annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities and www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
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Source: IntelGenx Technologies Corp.
(514) 331-7440 ext 232
Andre Godin, CPA, CA
Executive Vice-President and CFO
(514) 331-7440 ext 203