–Company to host conference call to discuss positive Phase 2 CYB003 interim results today, November 1, 2023 at 11:00 a.m. ET – – Complete Phase 2 topline data for CYB003 in MDD expected in Q4 2023 –
Cybin Inc. (NYSE American:CYBN) (NEO: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, today provided an update on its clinical-stage programs and key upcoming milestones across its development pipeline.
“The clinical progress we have made over the past few months is truly remarkable, exemplified by our recently released positive Phase 2 interim data for CYB003 in major depressive disorder (“MDD”), which demonstrated rapid and significant improvement in depression symptoms three weeks after a single dose. In coming months, we look forward to presenting the complete Phase 2 topline data for CYB003 in MDD, as well as Phase 1 data readouts for our proprietary novel deuterated N,N-dimethyltryptamine (“DMT”) compounds, CYB004 and SPL028.”
-Doug Drysdale, Chief Executive Officer of Cybin
Upcoming clinical milestones:
CYB003 – Deuterated Psilocybin Analog Program
- Complete Phase 2 topline safety and efficacy data readout for CYB003 in MDD, including 6-week data and results on the incremental benefit of a second dose expected in Q4 2023
- Submission of topline data to U.S. Food and Drug Administration (“FDA”) following readout, for an end of Phase 2 meeting in early 2024
- Additional Phase 2 data assessing durability of effect for CYB003 at 12 weeks expected in Q1 2024
- Progression to an international, multisite Phase 3 trial in early 2024 to further evaluate the safety and efficacy of CYB003 capsules in a larger MDD patient population, with recruiting expected to begin by end of Q1 2024
Deuterated DMT Program
- Phase 1 dosing, pharmacokinetic (“PK”) and pharmacodynamic (“PD”), and safety data for CYB004 and SPL028 expected in Q4 2023
- Initiate Phase 2 proof-of-concept study in participants with generalized anxiety disorder in Q1 2024
- A CYB004 subcutaneous formulation study in Q1 2024 in addition to the SPL028 formulation work
“Looking ahead, Cybin plans to run four clinical studies in 2024, reflecting the team’s strong execution on strategic priorities and commitment to accelerating our programs. We are in an exciting period of clinical development, and we look forward to sharing important data readouts across our pipeline of differentiated therapeutics.”
CYB003 Phase 2 Interim Results Conference Call and Webcast Details:
Date: Wednesday, November 1, 2023
Time: 11:00 a.m. ET.
Dial-in: 800-245-3047 (U.S. Toll-Free) or 203-518-9765 (International)
Conference ID: CYBN1101
Webcast: Register for the webcast here
The archived webcast will also be available on Cybin’s investor relations website on the Events & Presentations page.
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.