- Earlier studies show that CYB004 via inhalation may solve existing challenges and support a clinical path forward for this important therapeutic
- Cybin is currently developing CYB004 for the treatment of anxiety disorders
- The new chemical entity is covered by a patent issued earlier this year
Cybin (NEO: CYBN) (NYSE American: CYBN) has released data from a pharmacokinetic study focused on evaluating CYB004, the company’s proprietary deuterated dimethyltryptamine (“DMT”) molecule (https://ibn.fm/nyCj8). The study analyzed delivery methods of CYB004, and showed initial data indicates significant advantages over Intravenous (“IV”) and Inhaled DMT.
“In many studies, DMT has shown to be a promising and effective psychedelic for the treatment of mental health issues,” said Cybin CEO Doug Drysdale. “However, known side effects like disorientation and anxiety and its mode of administration have historically hindered its use and availability. CYB004 via inhalation may solve these challenges and finally support a clinical path forward for this important therapeutic.”
According to the report, inhaled CYB004 showed significant advantages over both IV DMT and inhaled DMT, including longer duration of action and improved bioavailability. The study also indicated that inhaled CYB004 showed an onset of effect and dose profile similar to IV DMT. “These data may support the potential for inhalation as a viable and well-controlled delivery system of therapeutic psychedelics,” the announcement states, noting that Cybin is currently developing CYB004 for treatment of anxiety disorders.
Specifically, the company reported that, based on preclinical results, inhaled CYB004 demonstrated:
- Approximately 2,000% improved bioavailability compared with orally administered DMT, which is known to have limited to no oral bioavailability
- Approximately 41% improved bioavailability compared with inhaled DMT
- Approximately 300% longer duration of effect when compared with IV DMT, indicating potential to extend the therapeutic window
- Rapid onset of effect and low variability equivalent to IV DMT
A new chemical entity, CYB004 is covered by a patent issued by the U.S. Patent and Trademark Office earlier this year. The patent allows claims that include a range of deuterated forms of DMT and 5-MeO-DMT. The composition of matter patent is expected to expire in 2041 before consideration of any patent term extensions.
“As part of Cybin’s overall mission to create safe and effective psychedelic-based therapeutics, inhaled CYB004 is being developed to potentially overcome the limitations of IV DMT and become an important treatment option for anxiety disorders for patients and physicians,” stated Drysdale. He also noted that the company plans to submit a regulatory filing for a pilot study in the coming weeks. “Cybin’s approach to psychedelic drug development enables the control of many biological factors, including improving the way a drug is metabolized and managing some adverse effects.
“In its natural form, DMT is unstable and not orally bioavailable,” Drysdale concluded. “Based on these preclinical studies, we believe CYB004 has the potential to overcome these issues. These results also provide strong evidence that an inhaled delivery mode may be able to address the limitations of IV DMT and could be widely applicable to a variety of psychedelics.”
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(TM) 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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