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

Rhea-AI Summary

IntelGenx Corp. (TSX:IGX) has announced the resumption of patient screening for its Montelukast VersaFilm® Phase 2a (BUENA) clinical trial in Alzheimer’s Disease after receiving a No Objection Letter from Health Canada. The trial had been previously paused due to COVID-19 concerns affecting high-risk patients. CEO Dr. Horst Zerbe expressed excitement about evaluating Montelukast’s potential, highlighting financial support from a recent convertible notes offering as key to continuing the study.

Positive

• Resumption of patient screening for Montelukast VersaFilm® Phase 2a clinical trial.
• Health Canada issued a No Objection Letter for the amended clinical trial application.
• Financial resources secured through convertible notes offering in Q3-2021 to complete the study.
• Demonstrated 52% higher bioavailability of Montelukast in Phase 1 studies.

Negative

• None.

SAINT LAURENT, Quebec, Oct. 12, 2021 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (“IntelGenx” or the “Company”)), a leader in pharmaceutical films, today announced its intention to resume patient screening in the ongoing Montelukast VersaFilm^® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”) following Health Canada’s (“HC”) issuance of a No Objection Letter (“NOL”) in response to IntelGenx’s amended Clinical Trial Application.

As previously disclosed in Q1-2020, IntelGenx received HC authorization to proceed with an amended BUENA clinical trial protocol, which enabled the Company to continue the trial at an increased daily dose. However, because the target study population in the BUENA study is considered to be a higher risk group for severe illness from COVID-19, and out of concern for the health and safety of clinical trial staff, IntelGenx informed HC in the second quarter of 2020 that the study was on a temporary recruitment hold. This NOL now paves the way for patient screening under the amended protocol to resume in October 2021.

“As treatment options remain limited, and no approved drugs are disease modifying, we are very excited to resume this trial and evaluate the potential of Montelukast as a much-needed treatment for AD patients,” said Dr. Horst Zerbe, IntelGenx’s CEO. “We are in the fortunate position that the convertible notes offering that closed in Q3-2021 provided us with the dedicated financial resources required to complete this important study, and expect to resume patient screening activities as soon as practicable this month.”

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 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

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 or forward-looking statements within the meaning of applicable United States and Canadian securities laws (collectively, “forward-looking statements”). These statements are statements that are not purely historical and include, but are not limited to, statements about the advancement of the New Loans and the obtaining of the TSX’s final approval to list its Common Shares on the TSX. 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, the factors 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 and www.sedar.com.

Although the Company believes that the expectations and assumptions on which forward-looking statements are based are reasonable, readers of this press release are cautioned not to rely unduly on such forward-looking statements since no assurance can be given that they will prove to be correct. The Company does not undertake any obligation to update or revise any forward-looking statements, whether as a result of events or circumstances occurring after the date of this press release, unless so required by legislation.

Source: IntelGenx Technologies Corp.

Contact Information:

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 Montelukast VersaFilm® Phase 2a trial about?

The Montelukast VersaFilm® Phase 2a trial aims to evaluate the safety and efficacy of Montelukast in patients with mild to moderate Alzheimer's Disease.

When will patient screening resume for the Montelukast trial?

Patient screening for the Montelukast trial is set to resume in October 2021.

What did the No Objection Letter from Health Canada entail?

The No Objection Letter from Health Canada allows IntelGenx to resume patient screening under the amended clinical trial protocol.

What is the significance of the convertible notes offering for IntelGenx?

The convertible notes offering provided IntelGenx with dedicated financial resources necessary to continue its clinical studies, including the Montelukast trial.

What advantages does Montelukast VersaFilm® have over traditional tablets?

Montelukast VersaFilm® offers improved bioavailability, ease of administration, and better patient compliance compared to traditional tablet formulations.