Cybin has selected Generalized Anxiety Disorder as the target indication for its proprietary deuterated N, N-dimethyltryptamine (“DMT”) molecule, CYB004.

CYB004 is the company’s 2nd main drug development program, a novel form of DMT Cybin believes has novel properties for potential therapies. The selection of anxiety disorders differentiates Cybin from other firms developing DMT (example Small Pharma is using DMT for depression)

See below for an update on CYB004 from Cybin’s recent end-of-year review:

Accelerated the development of CYB004 with the strategic acquisition of a Phase I DMT study (CYB004-E). The CYB004-E study evaluating IV N,N-dimethyltryptamine (“DMT”) is expected to yield essential safety and dosing optimization data that will inform further clinical advancement of CYB004 (deuterated DMT) for the treatment of anxiety disorders. To date, the trial has completed dosing of four out of five cohorts with no clinically significant safety or tolerability issues.

During the year, Cybin secured intellectual property (“IP”) protection for CYB004, including a U.S. patent covering CYB004 composition of matter and filed patent applications for inhalation delivery of multiple psychedelic molecules, including CYB004. In April 2022, the Company announced positive preclinical data demonstrating the significant advantages of CYB004 over intravenous and inhaled DMT, including rapid onset and longer duration of action. Cybin expects to provide an update on the Phase 1 CYB004-E study in the first quarter of 2023.

For more on Cybin’s DMT program, see Cybin Announces Positive Data on CYB004 DMT and Cybin Granted DMT Patent for CYB004

See the full press release below.

Cybin Selects Generalized Anxiety Disorder as Target Indication for Deuterated DMT Molecule CYB004

01/12/2023

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) (Cybin or the Company), a biotechnology company focused on progressing Psychedelics to Therapeutics® today announced that it has selected Generalized Anxiety Disorder (“GAD”) with or without major depressive disorder (“MDD”) as the target indication for its proprietary deuterated N, N-dimethyltryptamine (“DMT”) molecule, CYB004.

“Based on preclinical data, CYB004 has shown promise in treating anxiety disorders. About half of people suffering from depression are also burdened with GAD, which makes the need for more effective treatment options for GAD even more urgent,” said Doug Drysdale, Chief Executive Officer of Cybin. “Since the pandemic, the prevalence of depression and anxiety has been significantly elevated, and we are optimistic that through our current development programs, Cybin has the potential to provide innovative therapeutics to alleviate the mental suffering that so many people experience worldwide. We remain focused on the opportunity that CYB004, as a new chemical entity, may be able to provide a new path toward mental healing.”

Generalized anxiety disorder is characterized by excessive worry and tension that is not restricted to any specific environmental circumstances. Anxiety disorders are the most common mental health concern in the United States. Over 40 million adults in the U.S. (19.1% of the total U.S. population) have an anxiety disorder.1

Additional Facts about Anxiety and Generalized Anxiety Disorder:

• Among psychiatric disorders, GAD and MDD are the leading contributors to global disability. The presence of both GAD and MDD is strongly associated with a poor prognosis, an increase in severe symptoms, poorer quality of life, greater MDD recurrence, and a higher suicide risk than either disorder alone.2-5
• GAD affects 6.8 million adults, or 3.1% of the U.S. population, in any given year.6
• Women are twice as likely to be affected by GAD.6
• Worldwide, GAD affects 14.7 million people in any given year.7
• 23 % of adults prescribed an SSRI discontinued medication at 4 weeks and 36.5 % within 3 months. Another report indicated that approximately one half of patients discontinued antidepressant medication within 3 months. 8
• There is a lifetime morbidity risk for GAD, with around 9% prevalence.9
• Based on a 2022 Generalized Anxiety Disorder Therapeutics Market Report, the economic burden of GAD is expected to grow to US$12 billion by 2030.10

Cybin is currently conducting a Phase 1 exploratory trial (“CYB004-E trial”) evaluating IV N, N-dimethyltryptamine (“DMT”) to yield essential safety and dosing optimization data for the future clinical development of CYB004 for the treatment of GAD. To date, the CYB004-E trial has not demonstrated any clinically significant safety or tolerability issues. Cybin expects to translate key learnings from the initial study cohorts, including dose optimization and dosing dynamics, to support the remaining planned cohorts in the trial. These learnings are also expected to accelerate Cybin’s plans to commence dosing of CYB004 in humans.

In its natural form DMT is rapidly metabolized in the body and is not orally bioavailable. Based on preclinical studies, CYB004 has the potential to overcome the limitations of DMT. Specifically, these data showed that CYB004 had increased oral and pulmonary bioavailability, faster onset with lower doses, low inter-subject variability, and better dose titration for potentially fewer side effects compared with oral and IV DMT.

Cybin secured a U.S. composition of matter patent covering CYB004 in February 2022.

The Company plans to provide an update on its CYB004 program by the end of February 2023.