IntelGenx Provides Update on Phase 2a Montelukast VersaFilm™ Clinical Trial
Eight Alzheimer’s Disease Patients Randomized to Date with Two Additional Sites Expected
SAINT LAURENT, Quebec, Jan. 23, 2019 (GLOBE NEWSWIRE) — IntelGenx Corp. (IGX.V) (IGXT) (“IntelGenx”), a leading oral drug delivery company, today provided an update on its Phase 2a study of Montelukast VersaFilm™ in patients with mild to moderate Alzheimer’s Disease (AD).
To date, seven study sites across Canada have randomized eight subjects, many of which commenced dosing in late-2018. IntelGenx sponsored study sites are actively screening for new patients and IntelGenx expects enrollment to accelerate following the holiday season hiatus. In addition to opening its planned eighth trial site, IntelGenx is preparing to open an additional site in Montreal, bringing the total number of sites to nine.
“We are looking forward to commencing patient recruitment at our eighth site in the coming weeks, as well as opening an additional site in Montreal by the end of first quarter 2019,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “Although in its early stages, this is an exciting trial for IntelGenx as we work with our study sites to achieve a shared goal of finding a treatment that benefits patients living with this most unfortunate and debilitating disease.”
“Unlike traditional dosage forms, our Montelukast VersaFilm™ is engineered to deliver Montelukast with an improved bioavailability, which may be more efficacious than known Montelukast dosage forms in crossing the blood-brain barrier,” contends Dr. Zerbe. “As a result, our VersaFilm™ technology has the potential to be broadly applicable to a wide variety of other pharmaceutical treatment options.”
The randomized, double-blind, placebo-controlled Phase 2a “proof of concept” study will enroll approximately 70 subjects with mild to moderate AD. The study will evaluate the safety, feasibility, tolerability, and efficacy of Montelukast buccal film following daily dosing for 26 weeks.
About Montelukast VersaFilm™
Montelukast is a leukotriene receptor antagonist that was approved by the U.S. Food and Drug Administration in 1997 for the treatment of asthma and seasonal allergic rhinitis. IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. IntelGenx’s proprietary VersaFilm™ technology is especially suited for special needs patient populations, and the Montelukast VersaFilm™ product offers many distinct advantages over tablets for Alzheimer’s Disease 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 1 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’s oral film also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases.
About IntelGenx
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’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility, which was established for the VersaFilm™ technology platform, offers by supporting lab-scale to pilot- and commercial-scale production. More information about the company can be found at www.intelgenx.com.
Forward Looking Statements
This document may contain forward-looking information about IntelGenx’s 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’s 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’s 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’s 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 at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
For more information please contact:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com
Or
Andre Godin, CPA, CA
Executive Vice-President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com