IntelGenx Announces Enrollment Reaches Halfway Mark in ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease
IntelGenx announced that patient enrollment in the Montelukast VersaFilm® Phase 2a clinical trial for Alzheimer's Disease has reached the halfway mark, with a goal of 70 patients across up to eight sites. CEO Dr. Horst Zerbe expressed optimism regarding the enrollment pace, anticipating completion by year-end 2022. The Montelukast formulation aims to enhance bioavailability and compliance for patients. Prior Phase 1 studies indicated significant safety and effectiveness advantages over traditional tablet forms, suggesting a promising avenue for addressing neurodegenerative conditions.
- Patient enrollment in the Montelukast Phase 2a trial has reached halfway, indicating strong interest.
- Anticipated completion of patient enrollment by the end of 2022.
- Montelukast VersaFilm® shows 52% higher bioavailability compared to regular tablets.
- Prior studies confirm the safety and tolerability of the oral film formulation.
- None.
SAINT LAURENT, Quebec, Sept. 08, 2022 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that patient enrollment in the ongoing Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”) has reached the halfway mark.
This proof-of-concept study currently includes six clinical research sites with the potential of adding two more sites in the coming month, all of which are expected to enroll a total of approximately 70 patients.
"We are encouraged by the speed with which AD patients are enrolling in this trial following the resumption of our recruiting efforts," said Dr. Horst Zerbe, IntelGenx’s CEO. “We continue to work diligently to improve the recruitment rate even further, and anticipate completing enrollment before the end of 2022.”
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 Phase 1 studies, IntelGenx demonstrated that an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a
About IntelGenx
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.
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 offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.
Forward-Looking Information and 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.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
FAQ
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