- Manufacturing of both active and placebo films underway for planned 18-month study -

SAINT LAURENT, Quebec, July 25, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today announced the execution of a Research Grant Agreement with Karolinska University Hospital and that the manufacturing of both active and placebo films are underway in preparation for a planned multicentre, randomized, double-blind, placebo-controlled clinical study (the “Study”) to investigate the use of IntelGenx’s Montelukast VersaFilm® for the treatment of Parkinson’s Disease (“PD”).

The Study will be conducted at the Karolinska University Hospital under IntelGenx’s previously announced research collaboration with Per Svenningsson, MD, PhD, who will serve as the Study’s Principal Investigator. Dr. Svenningsson – a Professor of Clinical Neuroscience who investigates the pathogenic mechanisms of PD – previously conducted a clinical study utilizing the tablet form of Montelukast for the treatment of PD, where 2 tablets of 10 mg Montelukast were administered twice daily, for a total daily dose of 40 mg.

“Prof. Svenningsson’s interest in evaluating Montelukast VersaFilm® for the treatment of PD reflects his confidence in the drug’s therapeutic potential, which is based on findings from his earlier Montelukast tablet study, the higher bioavailability of our film formulation, as well as the need for a more convenient dosing method,” said Dwight Gorham, IntelGenx’s CEO. “As the planned study will assess Montelukast in doses exceeding 40 mg, Montelukast VersaFilm® offers study participants an attractive dosing alternative to tablets, which would require administration of multiple tablets several times per day.”

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. Upon completion of the Study, IntelGenx will have the option to acquire the developed intellectual property rights and study data for a predetermined low five-digit amount and use the findings to further develop its Montelukast VersaFilm® program for PD treatment.

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
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Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
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