IntelGenx Receives Approval to Conduct ’MONTPARK’ Montelukast VersaFilm® Phase 2 Clinical Trial in Patients with Parkinson’s Disease

Phase 2 MONTPARK trial expected to begin recruiting patients in Q1 2024

SAINT LAURENT, Quebec, Nov. 14, 2023 (GLOBE NEWSWIRE) — IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that the Swedish Medical Products Agency (“MPA”), the Swedish Ethical Review Authority, and the Regional Biobank Centre have approved the planned clinical study to investigate the use of IntelGenx’s Montelukast VersaFilm^® for the treatment of Parkinson’s Disease (“PD”).

PD is the second most common neurodegenerative disease after Alzheimer’s disease, 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. Early results have indicated its potential usefulness for the treatment of various neurodegenerative disorders like PD and Alzheimer’s Disease.

The Phase 2 MONTPARK study (CT number 2023-504278-39-00) is a 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. The study is expected to begin recruiting in Q1 2024 with an expected study duration of approximately 24-to-30 months, depending on the recruitment rate.

The study will be conducted at the Karolinska University Hospital and at 3 other Swedish University affiliated institutions under IntelGenx’s previously announced research collaboration with Per Svenningsson, MD, PhD, who will serve as the Study’s Principal Investigator. Prof. Svenningsson will sponsor the study through a 20 million Swedish Crowns grant (approx. $2 million USD) awarded by the Swedish Research Council, Sweden’s largest governmental research funding body.

“We are delighted that this trial has been approved by the MPA and look forward to beginning patient recruitment as soon as possible,” said Dwight Gorham, IntelGenx’s CEO. “We are excited to be collaborating with Prof. Svenningsson, a PD pathogenesis expert who previously demonstrated the safety and tolerability of 40 mg Montelukast in PD patients. MONTPARK will be evaluating daily Montelukast doses of 60 mg per day, making Montelukast VersaFilm^® a more attractive dosing method due to its increased bioavailability (approx. 50% improvement over tablets) and minimizing the need on a daily basis for the requirement of numerous 10 mg Montelukast tablets.”

Prof. Svenningsson stated, “Our study teams are quite eager and ready to commence the study with the novel IntelGenx Montelukast VersaFilm^® due to the beneficial features of the film in terms of ease of use, better compliance and bioavailability”.

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

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

Source: IntelGenx Technologies Corp.

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