Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, provides a corporate update highlighting recent clinical accomplishments and key upcoming catalysts across its development pipeline.
“With the prevalence and burden of mental health conditions at an all-time high, there is an urgent and growing need for improved treatments for depression and anxiety. Our team is dedicated to turning the tide of the mental health crisis through our clinical-stage programs. The past several months have been pivotal with FDA Breakthrough Therapy Designation for CYB003 and alignment on the Phase 3 design in major depressive disorder, and the start of our Phase 2 study of CYB004 in Generalized Anxiety Disorder. We are progressing quickly with both programs and expect the coming months to be transformative for Cybin, with a Phase 3 trial of CYB003 in MDD expected to begin this summer, and Phase 2 topline efficacy data for CYB004 in Q4 2024. The recent funding round provides us with the runway to achieve these important milestones.”
– Doug Drysdale, Chief Executive Officer of Cybin
CYB003: Lead program with FDA Breakthrough Therapy Designation for the adjunctive treatment of MDD
CYB003 is the first ever deuterated psilocybin analog program to enter clinical development and has demonstrated rapid and robust improvements in symptoms of depression with a single dose in a Phase 2 MDD study, with an incremental clinical benefit from a second dose and durable effects which were sustained to four months. The BTD by the FDA validates CYB003’s potential to show significant clinical improvements over existing treatments based on preliminary results and serves to expedite CYB003’s development pathway towards commercialization. Having achieved BTD and FDA alignment on a Phase 3 program design for CYB003, the Company plans to initiate a multinational, multisite Phase 3 MDD study in the summer of 2024.
Positive Phase 2 Results for CYB003 in MDD
- Rapid and large improvements in symptoms of depression after single doses with average 13.75 point difference in MADRS score reduction between CYB003 (12mg and 16mg pooled) and placebo at 3 weeks (p<0.0001)
- Incremental benefit of second dose with >75% response rates and up to 80% remission rates (12 mg) after second dose
- Efficacy sustained at 4 months after 2 doses, with a mean 22-point reduction in MADRS scores from baseline and robust remission rates of 60% (12 mg) and 75% (16 mg)
- Excellent safety and tolerability profile, with all reported AEs mild to moderate
CYB004: A proprietary deuterated N,N-dimethyltryptamine (“DMT”) program in development for the treatment of GAD
CYB004 is being developed as a highly scalable intermittent treatment. A single intramuscular (“IM”) dose is expected to result in acute psychedelic effects lasting an average of 90 minutes. The Company has initiated a Phase 2 study of IM CYB004 in participants with moderate to severe GAD, with topline data expected in Q4 2024. Results from this study are expected to provide proof-of-concept for CYB004’s efficacy in GAD, time to onset of effects, and durability of effects to one year.
CYB004 Phase 2 Program Outline
- Randomized, double-blind study in 36 participants with moderate to severe GAD (GAD-7 score ≥10) with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed.
- Two IM doses, three weeks apart vs. two low-dose controls
- Primary endpoint is change in Hamilton Anxiety Rating Scale (“HAM-A”) score from baseline at 6 weeks following second dose
- Other endpoints include the Montgomery-Asberg Depression Rating scale depression assessment, safety assessments, MEQ30 (psychedelic experience assessment) and EQ-5D-5L (quality of life assessment).
- Participants will be followed for a period of three months, with additional follow-up assessments up to a year
- Topline safety and efficacy results in Q4 2024
The Company’s intellectual property portfolio comprises over 50 granted patents and over 170 pending applications. 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 analogs, tryptamine derivatives, tryptamines compositions, inhalation delivery methods, combination drug therapies, and multiple classes of phenethylamine molecules. The Company’s intellectual property includes composition of matter patents supporting its clinical-stage CYB003 and CYB004 programs.
Clinical Facilitator Training Program (“EMBARK”)
EMBARK is a transdiagnostic, trans-drug, flexible model of psychological support for studies with psychedelics and provides facilitators the foundational training needed to provide skillful and ethical care to work with psychedelic therapeutics. The EMBARK Open Access platform is a free online course that offers foundational psychedelic facilitation training for healthcare professionals before they undergo a full training program. Cybin is also developing EMBARK for Clinical Trials (“EMBARKCT”), a scalable model of psychedelic facilitation training that will enable the Company to effectively screen, qualify, and train facilitators to participate in future pivotal trials.
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 healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog 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. For company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.