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IntelGenx Says Atai Life Sciences Collaboration Leads to Start of First-in-Human Clinical Study of Oral Thin Film Psychedelic Drug Candidate

IntelGenx Corp. (IGX.TO) on Thursday provided an update on its collaboration with its strategic partner, Atai Life Sciences (atai) for the development…

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IntelGenx Corp. (IGX.TO) on Thursday provided an update on its collaboration with its strategic partner, Atai Life Sciences (atai) for the development of novel formulations of pharmaceutical-grade psychedelics based on IntelGenx’s polymeric film technologies.

Under 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. The previously undisclosed candidate, buccal VLS-01, is a buccal film containing a synthetic form of N,N-dimethyltryptamine (DMT). Atai is developing the product as a therapy for treatment-resistant depression (TRD) along with Atai’s digital therapeutic designed to provide contextual “(mind)set-and-setting” support to patients before 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. 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.”

Dr. Horst G. Zerbe, CEO of IntelGenx

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