- Company receives FDA “may proceed” letter and investigational new drug (“IND”) application clearance
- Enrollment for Phase 1/2a trial has already started
- Upcoming trial is first time a psilocybin analog will be evaluated for MDD treatment
- Studies show psychedelic-based treatments may have potential to revolutionize mental healthcare, but few companies have assessed limitations of oral psilocybin
In a first-ever milestone, Cybin (NEO: CYBN) (NYSE American: CYBN) received approval from the U.S. Food and Drug Administration (“FDA”) (https://ibn.fm/QfXhX) to proceed with its planned phase 1/2a first in-human clinical trial and has started enrollment (https://ibn.fm/HxkKp). The study is designed to evaluate Cybin’s proprietary deuterated psilocybin analog, CYB003. The approval came in the form of a “may proceed” letter and investigational new drug (“IND”) application clearance.
“We are extremely pleased to advance CYB003 into clinical development so quickly,” said Cybin CEO Doug Drysdale. “Our team has worked diligently to achieve this major regulatory milestone, and we look forward to collaborating with Clinilabs, our drug-development partner, to accelerate this…
NOTE TO INVESTORS: The latest news and updates relating to CYBN are available in the company’s newsroom at https://ibn.fm/CYBN
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