IntelGenx Announces First Parkinson’s Disease Patients Dosed with Montelukast VersaFilm® in Phase 2 ‘MONTPARK’ Clinical Trial

SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) — IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that Montelukast VersaFilm^® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial.

MONTPARK (EudraCT number 2023-504278-39-00) is a Phase 2, randomized, double-blind, placebo-controlled, parallel arm, multicentre trial that will investigate the efficacy of oral high-dose Montelukast on the progression of early-to-moderate PD. The study will enroll up to 90 patients who will receive 30 mg Montelukast VersaFilm^® or placebo twice daily for 18-months, followed by a 3-month washout period. Eligible candidates must be on levodopa treatment at the time of enrolment and may also be on other dopaminergic symptomatic agents. MONTPARK is being conducted at the Karolinska University Hospital and at three other Swedish University affiliated institutions under IntelGenx’s previously announced research collaboration with Per Svenningsson, MD, PhD, who is serving as the study’s Lead Principal Investigator.

“Dosing of the first PD patients in the Phase 2 MONTPARK trial represents a major milestone in the clinical development of Montelukast VersaFilm^®, which is also being investigated for the treatment of mild to moderate Alzheimer’s Disease, or AD, in the ongoing ‘BUENA’ Phase 2a study,” said Dwight Gorham, IntelGenx’s CEO. “As treatment options for neurodegenerative diseases like PD and AD remain limited, with studies such as MONTPARK and BUENA, we are taking significant steps closer to providing patients with a novel, disease-modifying treatment that also offers a dosing method that is especially suited to their needs.”

About Parkinson’s Disease

PD is the second most common neurodegenerative disease after AD, with an estimated 9 million patients globally and 1 million patients in the United States.^1,2 In the United States it is estimated that 90,000 new patients will be diagnosed with PD every year.² No neuroprotective or disease-modifying treatments are currently available. The current standard treatment of PD motor dysfunction is based on the enhancement of dopaminergic transmission and involves the administration of L-dopa. Evidence from multiple patient studies and animal models has shown a significant immune component during the course of the disease, highlighting immunomodulation as a potential treatment strategy.³ Montelukast is a CysLT₁ antagonist which decreases neuroinflammation by inhibiting CysLT₁.

About Montelukast VersaFilm^®

Montelukast 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, such as PD and AD, 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 PD and 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 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.

References

¹ World Health Organization: https://www.who.int/news/item/14-06-2022-launch-of-who-s-parkinson-disease-technical-brief#:~:text=Globally%2C%20the%20prevalence%20of%20Parkinson,million%20individuals%20living%20with%20PD

² Parkinson’s Foundation: https://www.parkinson.org/understanding-parkinsons/statistics

³ Wallin, J; Svenningsson, P. Potential Effects of Leukotriene Receptor Antagonist Montelukast in Treatment of Neuroinflammation in Parkinson’s Disease. Int. J. Mol. Sci. 2021, 22, 5606

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.sedarplus.ca. IntelGenx assumes no obligation to update any such forward-looking statements.

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
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stephen@kilmerlucas.com

Or

Andre Godin, CPA, CA
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IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com