FDA Green Lights Cybin's Psychedelic Clinical Study Assessing Generalized Anxiety

Psychedelics biotech Cybin Inc. CYBN has received clearance from the Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for CYB004, its novel deuterated DMT molecule for Generalized Anxiety Disorder (GAD) treatment. This will enable the company to initiate a Phase 2a study in Q1 2024.

Ciphers show anxiety disorders are reported among the most prevalent mental health disorders globally and contribute to some 28 million disability-adjusted life years (DALYs). Specifically, GAD is the most common anxiety disorder seen in primary care, with a 12-month prevalence of 2.9% across the U.S.

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CEO Doug Drysdale says the Cybin team is "committed to developing improved treatment options with the goal of improving the quality of life for people suffering from anxiety disorders worldwide."

To be conducted in U.S.-based sites, the new Phase 2a study will be a randomized, double-blind, active-controlled trial to test the initial clinical efficacy, safety and tolerability of CYB004 in participants with GAD.

The trial follows recently published positive topline results from two Phase 1 studies of the company's two deuterated DMT molecules, CYB004 and SPL028. 

Cybin's five completed clinical studies on DMT and deuterated DMT have provided the company with relevant insights on dosing and preliminary efficacy signals in both depression and anxiety, to inform the next clinical development steps. 

Drysdale highlighted the exploratory data of the Phase 2a study on SPL026 (IV DMT,) showing the compound reduced anxiety symptoms in patients with Major Depressive Disorder (MDD.) This, he said, would further serve to de-risk the development of deuterated DMT in anxiety disorders while Cybin continues evaluating CYB004's efficacy and safety.

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