- 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 program. This phase 1/2a trial represents the first time that a psilocybin analog will be evaluated for the treatment of MDD and is the key next step toward our ultimate goal of providing a new and effective treatment for people suffering with mental health conditions.
“Successful patient recruitment and a proper clinical environment are integral components of this trial,” Drysdale also noted. “As a global leader in drug development services, Clinilabs is a perfect partner, and we are thankful for their support and guidance.” According to the company, this is the industry’s first-ever novel psilocybin analog to enter clinical development.
Participants in the randomized, double-blind, placebo-controlled study will receive two administrations: placebo/active and active/active. In addition, a response/remission will be assessed after the first dose at week 3 and after the second dose at week 6. The announcement noted that study subjects currently being treated with selective serotonin reuptake inhibitors can remain on their antidepressant medication.
Specifically, the phase 1/2a study is designed to evaluate rapid onset of antidepressant effect on the day of dosing, as well as the benefit of CYB003 when administered at up to two 12mg doses. An optional open-label follow-up study will assess the durability of treatment effect out to 12 weeks. The study will use the Montgomery-Asberg Depression Rating Scale.
Cybin plans to provide an interim pharmacokinetic (“PK”) and safety data readout in quarter four of this year. The company anticipates that data from the studies will provide key PK and safety data to help the company identify future plans for its proprietary substance.
“Multiple academic studies have shown that psychedelic-based treatments, like psilocybin, may have the potential to revolutionize mental healthcare, but few companies have addressed the well-known limitations and side effects of oral psilocybin,” said Drysdale. “We believe CYB003 has the potential to offer people in need a more tolerable and potentially more effective treatment option. We look forward to advancing this important compound through clinical development.”
A deuterated analog of psilocybin, CYB003 is designed to effectively address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action and shorter duration of effect. “We believe CYB003 has the potential to reduce time and resource burden on patients, providers and payers, and possibly improve scalability and accessibility of treatment,” the company stated.
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom and Ireland. The company is focused on progressing psychedelics to therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
For more information, visit the company’s website at www.Cybin.com.
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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