00:16:20 EDT Sat 27 Apr 2024
Enter Symbol
or Name
USA
CA



Cybin Inc
Symbol CYBN
Shares Issued 205,607,413
Close 2023-06-07 C$ 0.31
Market Cap C$ 63,738,298
Recent Sedar Documents

Cybin expects CYB003, CYB004 trial data in Q3 2023

2023-06-08 11:51 ET - News Release

Mr. Doug Drysdale reports

CYBIN INC. PROVIDES CORPORATE UPDATE

Cybin Inc. has provided a corporate update outlining access to capital and upcoming clinical milestones.

"The second half of 2023 will be pivotal for Cybin as we expect top-line clinical data readouts from both our phase 1/2a trial of CYB003, our deuterated psilocybin analogue, and from our phase 1 trial of CYB004, our deuterated DMT [N,N-dimethyltryptamine] molecule. Through a combination of the company's recently announced common share purchase agreement from Lincoln Park Capital Fund and the ongoing at-the-market offering, the company has done an admirable job of securing access to capital in light of current market conditions. The potential access to capital should provide Cybin with the cash runway needed to complete these value-driving clinical milestones and enable us to continue focusing on clinical execution, with the ultimate goal of bringing improved therapeutic options to patients in need," said Doug Drysdale, chief executive officer of Cybin.

CYB003: A proprietary deuterated psilocybin analogue for the potential treatment of major depressive disorder

CYB003 is the first ever deuterated psilocybin analogue to enter clinical development and its therapeutic profile as a potentially differentiated treatment for major depressive disorder (MDD) has been highlighted in poster presentations at multiple scientific conferences.

Interim findings from the company's continuing phase 1/2a clinical trial evaluating CYB003 demonstrated positive observations, including a rapid and short-acting psychedelic response in participants. Participants received single oral doses of CYB003 at one milligram (mg), three mg, eight mg and 10 mg, respectively, and all doses were well tolerated, with no serious adverse events reported. Most notably, participants reported meaningful and robust psychedelic effects at the eight mg and 10 mg doses, confirming a complete mystical experience was achieved. These interim findings demonstrate that CYB003 was rapid and short acting, and reached a psychedelic effect at low doses, while maintaining a safe and well tolerated therapeutic profile.

CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. CYB003's therapeutic profile as a potentially differentiated treatment for MDD is expected to provide consistent and predictable dosing, with the goal of reducing time and resource burden on the health care system.

Upcoming milestones for the CYB003 program:

  • Completion of CYB003 dosing in MDD cohorts expected in Q3 2023;
  • Top-line efficacy data readout from CYB003 phase 1/2a clinical trial expected in late Q3 2023;
  • United States Food and Drug Administration (FDA) submission of CYB003 phase 1/2a data for pivotal studies expected in Q4 2023.

CYB004: A proprietary deuterated N,N-dimethyltryptamine (DMT) molecule

CYB004 is being evaluated as a potential treatment for generalized anxiety disorder. CYB004 is secured by a U.S. composition of matter patent, with protection through 2041. The patent covers a range of deuterated forms of DMT and protects CYB004 as a putative new chemical entity.

DMT has been shown to exert its psychedelic effects by activating the 5-HT2A receptor. In its regular form, DMT is an unstable molecule rapidly metabolized in the body, which significantly reduces its bioavailability. By developing CYB004 as a deuterated molecule and improving upon the bioavailability of DMT, CYB004 has the potential to overcome the existing limitations of DMT, and offer less invasive and more convenient dosing methods.

The company anticipates announcing top-line data readout, including safety, dosing, and pharmacokinetic (PK) and pharmacodynamic (PD) data from the phase 1 study of CYB004 in late Q3 2023.

Intellectual property portfolio

The company's intellectual property portfolio now encompasses more than 50 granted or pending patent applications across six patent families, through a combination of internal and licensing arrangements. The issued patents and pending applications cover a broad range of molecules, drug combinations and delivery mechanisms, including but not limited to amorphous psilocybin, psilocybin analogues, tryptamine derivatives, tryptamines compositions, inhalation delivery methods, combination drug therapies and multiple classes of phenethylamine molecules.

Clinical facilitator training program (Embark)

Embark is a transdiagnostic, flexible model of psychedelic facilitation training developed by Cybin, and was born out of a desire to build upon the successes and shortcomings of previous psychological support approaches to create a model that enables participants to receive maximum benefit. Embark provides six clinical domains (existential-spiritual, mindfulness, body aware, affective-cognitive, relational and keeping momentum). Embark is built upon four care cornerstones: trauma-informed care, culturally competent care, ethically rigorous care and collective care. The Embark Open Access platform is a free on-line course that offers psychedelic facilitation training for health care professionals and people interested in offering psychological support.

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. The company 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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