Cybin Updates on Upcoming Clinical Milestones

Cybin Inc., a clinical-stage neuropsychiatry company focused on innovative treatment options for mental health conditions, has announced significant progress and upcoming milestones in its clinical programs. The company is developing two main programs: CYB003 for Major Depressive Disorder (MDD) and CYB004 for Generalized Anxiety Disorder (GAD).

CYB003 is a proprietary deuterated psilocin program designed for the adjunctive treatment of MDD. This program has received FDA Breakthrough Therapy Designation, which underscores its potential for significant clinical improvement over existing treatments and accelerates its path to commercialization. Notable upcoming milestones include the initiation of a pivotal Phase 3 study for CYB003, expected to commence imminently. The study will take place at 30 high-quality clinical sites across the United States and Europe.

In preparation for this phase, Cybin held a productive Type B Initial Breakthrough Therapy Meeting with the FDA in August 2024. The Phase 3 trial design addresses critical methodological issues, such as functional unblinding, which are essential for the evaluation of drugs in this category. Prior Phase 2 results demonstrated rapid and substantial improvements in depression symptoms with a single dose of CYB003, maintaining effects for four months with a 75% remission rate in the 16mg dose group. The company anticipates reporting 12-month efficacy data from this Phase 2 study in early Q4 2024, offering further insights into CYB003's potential for long-term relief for MDD patients.

CYB004, on the other hand, is a proprietary deuterated dimethyltryptamine (DMT) program aimed at treating GAD. This program is expected to be a highly scalable intermittent treatment with an intramuscular (IM) formulation, optimizing the delivery of CYB004. The acute effects of this treatment last approximately 90 minutes. Currently, dosing is underway in a Phase 2 study involving participants with moderate to severe GAD. The study's results will establish proof-of-concept for CYB004's efficacy, time to onset of effects, and durability of effects over one year. Cybin plans to disclose topline safety and efficacy results by year-end 2024 or early Q1 2025.

The Phase 2 study for CYB004 is a randomized, double-blind trial involving 36 participants with moderate to severe GAD. The primary endpoint is the change in Hamilton Anxiety Rating Scale (HAM-A) score from baseline at six weeks following the second dose. Participants will receive two IM doses three weeks apart, with additional follow-up assessments up to one year.

Cybin has also fortified its research and development team by appointing two experienced drug development leaders. Dr. Atul R. Mahableshwarkar, a board-certified psychiatrist and accomplished drug development executive, will lead the CYB003 program. Dr. Tom Macek, who has extensive pharmaceutical industry experience across various phases of drug development, will head the CYB004 program.

Founded in 2019 and headquartered in Canada, Cybin aims to revolutionize mental healthcare through next-generation therapeutics. The company is active in Canada, the United States, the United Kingdom, the Netherlands, and Ireland. Its mission is supported by a network of world-class partners and internationally recognized scientists focused on advancing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches, and treatment regimens.