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Cybin Inc
Symbol CYBN
Shares Issued 410,855,285
Close 2024-03-15 C$ 0.61
Market Cap C$ 250,621,724
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Cybin begins phase 2 CYB004 study for GAD treatment

2024-03-15 09:12 ET - News Release

Mr. Doug Drysdale reports

CYBIN INITIATES PHASE 2 PROOF-OF-CONCEPT STUDY OF CYB004 IN GENERALIZED ANXIETY DISORDER

Cybin Inc. has initiated a phase 2 proof-of-concept study of CYB004, its proprietary DMT (N,N-dimethyltryptamine) molecule in development for the treatment of GAD (generalized anxiety disorder). In January, 2024, the United States Food and Drug Administration (FDA) cleared Cybin's investigational new drug application for CYB004.

"Initiation of the phase 2 study of CYB004 for GAD is an exciting step forward for our deuterated DMT program," said Doug Drysdale, chief executive officer of Cybin. "One of our most important goals is to achieve a scalable, short-duration psychedelic experience for the patient, in the hopes of potentially disrupting negative, ruminative thought patterns. We are building on foundational investigative work from our phase 2a trial of intravenous SPL026 (DMT) which showed preliminary evidence of effectiveness treating anxiety with rapid onset of antidepressant effects and reduction in anxiety scores.

"This week, we also announced three important catalysts for our other novel psychedelic molecule, CYB003, for the adjunctive treatment of major depressive disorder: (1) we had a positive end-of-phase-2 meeting with the FDA, gaining alignment on our phase 3 program design; (2) CYB003 was granted breakthrough therapy designation by the FDA; and (3) we shared positive four-month durability data which support a pivotal phase 3 multinational study in mid-2024. With two lead clinical programs progressing rapidly, we are committed to leading the way to address the challenges of mental health care today," concluded Mr. Drysdale.

CYB004 phase 2 program outline

The CYB004-002 phase 2 study is a randomized, double-blind study which will evaluate the safety and efficacy of CYB004 in participants with GAD, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed:

  • The study will recruit approximately 36 participants, who will be randomized in a double-blind manner, into two groups: the first group will receive two IM (intramuscular) doses of CYB004, three weeks apart, while the second group will receive two low-dose control administrations.
  • The study will enroll participants with moderate to severe GAD, and a score of greater than or equal to 10 on the GAD-7 anxiety scale.
  • Participants will be followed for a period of three months, with an optional additional assessment at six months.
  • The primary end point is a change in the Hamilton Anxiety Rating Scale (HAM-A) score from baseline at six weeks following the second dose.
  • Other end points include the Montgomery-Asberg depression rating scale depression assessment, safety assessments, MEQ30 (psychedelic experience assessment) and EQ-5D-5L (quality of life assessment).
  • Results from this study are expected to provide proof of concept for CYB004's efficacy in GAD, the time to onset of effects, as well as durability of effects to six months.
  • Top-line safety and efficacy data from this phase 2 CYB004-002 study are expected in fourth quarter 2024.

Significant unmet medical need in generalized anxiety disorder

Anxiety disorders affect over 40 million adults in the United States each year. In the United States, GAD is the most common anxiety disorder seen in primary care, with a 12-month prevalence of 2.9 per cent. Despite the use of existing therapies, 50 per cent of patients with GAD do not respond to first-line treatment with antidepressants such as SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin and norepinephrine reuptake inhibitors), highlighting a large treatment gap and urgent need for improved therapeutic options.

About Cybin Inc.

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin's goal of revolutionizing mental health care is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens. Cybin is currently developing CYB003, a proprietary deuterated psilocybin analogue for the treatment of major depressive disorder, and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder, and has a research pipeline of investigational psychedelic-based compounds.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland.

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