The company noted it will conduct the trial at study sites in the United States.
The U.S. Food and Drug Administration has cleared the investigational-new-drug application for CYB004, Cybin’s proprietary deuterated dimethyltryptamine (DMT) molecule in development for the treatment of generalized anxiety disorder, the company said.
With FDA clearance, Cybin said it can proceed with its plans to initiate a Phase 2a study of CYB004 in the first quarter of 2024.
The Phase 2a study will be a randomized, double-blind, active-controlled trial to assess the preliminary clinical efficacy, safety, tolerability, PK and PD of CYB004 in participants with generalized anxiety disorder, according to Cybin.
The company noted it will conduct the trial at study sites in the United States.
“With the recent positive top-line results from two Phase 1 studies of our proprietary deuterated DMT molecules, CYB004 and SPL028, we are well-positioned to initiate a Phase 2a study of CYB004 in GAD this quarter,” Cybin CEO Doug Drysdale said. “From our extensive portfolio of DMT and deuterated DMT datasets across five completed clinical studies, we have gathered important insights on dosing and preliminary efficacy signals in both depression and anxiety that will inform our next steps. Exploratory data from our completed Phase 2a study of SPL026 (IV DMT) have shown that SPL026 reduced symptoms of anxiety in patients with major depressive disorder, which further serves to de-risk the development of deuterated DMT in anxiety disorders as we continue to evaluate the efficacy and safety of CYB004.”
In a news release, Cybin cited data indicating that anxiety disorders are the most prevalent mental-health disorders globally, contributing to more than 28 million disability-adjusted life years.
“Although anxiety disorders are one of the most prevalent mental health disorders, current treatment options remain limited, with suboptimal response and remission rates,” Drysdale added. “We are committed to developing improved treatment options with the goal of improving the quality of life for people suffering from anxiety disorders worldwide. We look forward to exploring the potential of CYB004 to offer more convenient and patient-friendly dose forms and treatment duration.”