First Patient Dosed in IntelGenx’s Resumed ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease

Rhea-AI Summary

IntelGenx Corp. (TSX:IGX) announced the resumption of patient dosing in its Phase 2a "BUENA" clinical trial for mild to moderate Alzheimer’s Disease after a COVID-related hiatus exceeding one year. This advancement highlights the ongoing repurposing of Montelukast VersaFilm®, with expectations for valuable insights into its safety and efficacy. Dr. Horst Zerbe, CEO, emphasized the significance of this milestone, while Dr. Ludwig Aigner noted the urgent need for effective AD treatments, positioning Montelukast VersaFilm® as a potential game-changer.

Positive

• Resumption of patient dosing in the BUENA trial signifies a major milestone.
• Potential for Montelukast VersaFilm® to address unmet medical needs in Alzheimer's Disease.

Negative

• Interruption of the trial for over a year due to COVID-19 may raise concerns about timelines and efficacy.

SAINT LAURENT, Quebec, Jan. 20, 2022 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (“IntelGenx” or the “Company”), a leader in pharmaceutical films, today announced that patient dosing has resumed in the ongoing Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”) under a previously amended protocol using higher doses of Montelukast VersaFilm^®.

“Resumption of patient dosing after a COVID-related interruption of the study of over one year is a significant milestone for this novel drug repurposing program, and we look forward to the BUENA trial producing valuable data that will provide more complete insight into the safety, feasibility, tolerability and efficacy of Montelukast VersaFilm^® in patients with mild to moderate AD,” commented Dr. Horst Zerbe, IntelGenx’s CEO.

“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.”

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 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

What is the purpose of the BUENA clinical trial for IGXT?

The BUENA trial aims to evaluate the safety, feasibility, tolerability, and efficacy of Montelukast VersaFilm® in patients with mild to moderate Alzheimer's Disease.

What are the expected outcomes from the resumed BUENA trial?

The trial is expected to provide valuable data related to the treatment's safety and effectiveness in Alzheimer's patients.

How long was the BUENA clinical trial paused for?

The trial was paused for over one year due to COVID-19 interruptions.

What does the resumption of the trial mean for investors in IGXT?

The resumption may positively influence investor sentiment by indicating progress in clinical development and potential market impact.

What does Montelukast VersaFilm® aim to achieve for Alzheimer’s patients?

Montelukast VersaFilm® aims to provide a safe and effective treatment option, potentially modifying the disease progression in Alzheimer's patients.