atai Life Sciences Announce First Subject Dosed in Synthetic DMT Phase 1 Trial

atai Life Sciences Announce First Subject Dosed in Synthetic DMT Phase 1 Trial

  • atai has administered the first dosage of their VLS-01 synthetic DMT drug in their Phase 1 single-ascending dose (SAD) trial, with topline results expected to come back sometime during the first half of 2023.
  • VLS-01 is a synthetic form of N, N-dimethyltryptamine (DMT) being developed to treat depression that doesn’t respond to other treatments. atai’s digital therapeutic will provide support to patients before they take the VLS-01 dose. This includes helping them understand how the environment and mindset can affect their experience.
  • More than 100 million people worldwide suffer from treatment-resistant depression.

atai Life Sciences N.V. (Nasdaq: ATAI) recently announced the dosing of the first subject in their Phase 1 SAD trial of VLS-01, a form of N, N-dimethyltryptamine (DMT) for the treatment of treatment-resistant depression (TRD).

About atai Life Sciences

atai Life Sciences is a clinical-stage biopharmaceutical company that aims to transform the treatment of mental health disorders. atai is a new, rapidly growing company that was formed in 2018 to address the significant unmet need and lack of innovation in the mental health treatment market. atai’s mission is to identify, acquire, and incubate innovative therapies for depression, anxiety, addiction, and other mental health issues.

atai aims to responsibly advance the development of new medicines across its enterprises by pooling resources and best practices to create clinically meaningful and long-term behavioral change in persons with mental illness. The company’s goal is to treat mental health disorders so that people all over the world can live happier lives.

atai Life Sciences Phase 1 Trial of Synthetic DMT VLS-01

The trial is designed to compare the bioavailability of buccal (inside the cheek) versus IV (intravenous) formulations of VLS-01, as well as assess its safety and tolerability administered by both routes. In addition, the pharmacodynamics study will use qEEG (quantitative electroencephalography) measures and other tools to evaluate DMT’s effects.

Buccal VLS-01 has the potential to provide a psychedelic experience that lasts only 30 to 45 minutes, as opposed to other compounds which may require the patient to be monitored for four hours or more. As a result, clinic visits may be shorter than with other drugs.

The trial not only encompasses the use of atai’s IDEA-1 digital therapeutic app, but also behavioral activation therapy, group therapy, and patient monitoring post-dosing. These behavioral assessments from the trial aim to provide data that can be used to design future Phase 2 clinical trials of VLS-01. The pharmacokinetic and safety readouts from these trials will also inform the trial design.

The Need for Psychedelics in Treatment-Resistant Depression

Approximately 100 million people live with treatment-resistant depression worldwide – or a third of all persons suffering from depression – who are undertreated or unresponsive to existing therapy options. In addition to its impact on patients, families, and caregivers, TRD has a major economic cost for healthcare systems and health insurance companies.

On average, TRD patients have medical expenses that are twice as high as non-TRD major depressive disorder (MDD) patients. This is due to more inpatient visits and hospital stays that are over one-third longer.

Srinivas Rao, Chief Scientific Officer of atai Life Sciences recently expanded on the need stating, “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.”

atai said the company is pleased to see the trial move forward as they establish the safety and tolerability of the compound with topline results anticipated in H1 2023.

“Given the scale of the depression crisis, the impact on patients and families could be enormous,” said Senior Vice President of Early Development of atai Life Sciences, Glenn Short.

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