IntelGenx’s Collaboration with atai Life Sciences Culminates in the Initiation of First-in-Human Clinical Study of an Oral Thin Film Psychedelic Drug Candidate

Rhea-AI Summary

IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) has announced a collaboration update with atai Life Sciences for developing pharmaceutical-grade psychedelic formulations using IntelGenx's polymeric film technologies. The buccal film candidate, VLS-01, contains a synthetic form of N,N-dimethyltryptamine and is aimed at treating treatment-resistant depression (TRD). The initial dosing in the Phase 1 clinical trial has commenced, with topline results expected in H1 2023. This move marks a significant milestone for IntelGenx as they explore innovative drug delivery methods.

Positive

• Initiation of Phase 1 clinical trial for buccal VLS-01.
• Collaboration with atai Life Sciences for novel therapeutic development.
• Potential of VLS-01 to address unmet needs in treatment-resistant depression.

Negative

• None.

SAINT LAURENT, Quebec, Oct. 13, 2022 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today provided an update on its collaboration with its strategic partner, atai Life Sciences (NASDAQ:ATAI) (“atai”), for the development of novel formulations of pharmaceutical-grade psychedelics based on IntelGenx's polymeric film technologies.

Pursuant to the first of two current feasibility agreements between the companies, IntelGenx conducted pre-development, formulation development work and clinical supply manufacturing to provide a product prototype to atai for further clinical investigation. That previously undisclosed candidate, buccal VLS-01, is a buccal film containing a synthetic form of N,N-dimethyltryptamine. atai is developing the product as a novel therapy for treatment-resistant depression (“TRD”) in combination with atai’s digital therapeutic designed to provide contextual “(mind)set-and-setting” support to patients prior to dosing.

“We were very pleased with atai’s recent announcement that it had dosed the first subject in its Phase 1 clinical trial of buccal VLS-01, with topline results expected in H1 2023,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “The initiation of this first-in-human study of a pharmaceutical-grade psychedelic buccal film drug candidate represents the achievement of another major milestone for IntelGenx, and what we expect will be the first of many for our strategic partnership with atai.”

“Exploring novel approaches to drug delivery can potentially simplify in-clinic administration and allow greater pharmacokinetic control of the psychedelic experience and its overall duration of hallucinogenic effects,” said Dr. Srinivas Rao, Chief Scientific Officer of atai Life Sciences, said in a recent statement. “We’re pleased to see this trial move forward as we establish the safety and tolerability of our compound.”

An estimated 100 million people live with TRD globally – or a third of people with depression – who are undertreated or unresponsive to available treatment options. In addition to its impact on patients, families, and caregivers, TRD significantly burdens healthcare systems and payers. Direct medical costs for TRD patients are estimated to be two times higher than for non-TRD major depressive disorder patients, with an average of twice the number of inpatient visits and hospital stays that are over one-third longer.

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
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 significance of the VLS-01 trial for IntelGenx?

The initiation of the Phase 1 clinical trial for VLS-01 represents a major milestone for IntelGenx, marking their advancement in developing psychedelic therapies.

What is the target condition for the VLS-01 treatment?

VLS-01 is being developed as a novel therapy for treatment-resistant depression (TRD).

When are the topline results of the VLS-01 trial expected?

Topline results from the Phase 1 clinical trial of VLS-01 are anticipated in the first half of 2023.

What is the potential market impact of VLS-01?

With an estimated 100 million people affected by treatment-resistant depression globally, VLS-01 could significantly impact healthcare by providing new treatment options.