The first patient has now been dosed in IntelGEnx and atai Life Sciences’ Phase 1 clinical trial to investigate buccal VLS-01 – a buccal film containing a synthetic form of DMT – as a novel therapy for treatment-resistant depression (TRD).
atai is developing the product as a novel therapy for TRD in combination with its digital therapeutic which is designed to provide contextual “set-and-setting” support to patients prior to dosing.
IntelGenx conducted pre-development, formulation development work and clinical supply manufacturing to provide the product prototype to atai.
CEO of IntelGenx, Dr Horst G. Zerbe, commented: “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, and what we expect will be the first of many for our strategic partnership with atai.”
Chief scientific officer of atai Life Sciences, Dr Srinivas Rao, said in a recent statement: “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.
“We’re pleased to see this trial move forward as we establish the safety and tolerability of our compound.”
There is an estimated 100 million people living with TRD globally – around one third of people with depression.
Whilst impacting on patients, families, and caregivers, the condition also 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.
This demonstrates a vital need for new and innovative therapies to help patients with TRD.
