Psychedelic drug firm hails FDA commissioner’s support for accelerated therapy research

Cybin, a clinical-stage neuropsychiatry company developing psychedelic-based therapies, has applauded recent comments made by US FDA Commissioner Dr. Martin Makary relating to the importance of accelerating and prioritizing research on the clinical benefits of psychedelic therapeutics.

“It is gratifying that the FDA commissioner shares our belief in the potential therapeutic value of these innovative treatments — a long-held belief that stands at the core of Cybin’s mission,” says Cybin CEO, Doug Drysdale.

“We are doing the rigorous investigative clinical work to unlock the potential of this class of drugs to effectively treat a variety of disorders, including major depressive disorder and generalized anxiety disorder.”

“We agree wholeheartedly that the time is now to address the mental health crisis, and we applaud Dr. Makary’s commitment to expedite the regulatory review process for product candidates in development and to get them into the hands of providers and patients as soon as possible.”

Clinical trial advances

Cybin’s clinical program includes two key psychedelic compounds. CYB003, a deuterated psilocin, is in Phase 3 research for major depressive disorder. A second study in this stage is expected to begin around mid-2025.

In Phase 2, 100% of participants receiving two 16 mg doses were responders, 71% achieved remission, and there was an average 23-point reduction in MADRS scores.

Meanwhile, CYB004, a deuterated DMT, is in Phase 2 for generalized anxiety disorder, with study completion anticipated by mid-2025.

“Cybin is committed to advancing its clinical-stage programs toward potential regulatory review and approval,” says Drysdale.

“Our CYB003 deuterated psilocin program, which is currently in Phase 3 development, has been granted FDA Breakthrough Therapy Designation for the adjunctive treatment of MDD, which could expedite drug development timelines.”

“We are encouraged by our ongoing positive interactions with the FDA and by the agency’s stated focus and openness to innovative treatments that show promise, even when they challenge traditional standards of care. This public endorsement that psychedelics are a ‘frontier area’ with compelling scientific evidence is welcome validation for the work we do every day.”

Next wave of the shroom boom

A study in Nature this month found that psychedelic compounds interact with brain-immune system pathways and “fundamentally reshape” immunity responses tied to fear and stress. As such, the study reveals that psychedelics can do more than change perception — they can help dial down inflammation and reset brain-immune interactions.

In April, scientists found a single dose of a psychedelic compound boosted cognitive flexibility for weeks, with potential impacts on treatments for depression, post-traumatic stress disorder, and neurodegenerative diseases such as Alzheimer’s disease. 

Meanwhile, a separate study revealed that the natural compound psilocybin can boost mood and brain health for patients with Parkinson’s disease. Previous research has also suggested that the compound from magic mushrooms is a more effective treatment for symptoms of depression than controls.