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Cybin Makes Significant Progress in Mental Health Treatment Development

Cybin Inc., a clinical-stage biotech company, has achieved notable advancements in its CYB003 and CYB004 programs aimed at treating Major Depressive Disorder and Generalized Anxiety Disorder, respectively. The company has received FDA Breakthrough Therapy Designation for CYB003, finalized site selection for its Phase 3 study, and started a Phase 2 study for CYB004, showcasing a robust financial status.

Cybin Inc., a clinical-stage biotech firm, has reported significant strides in the development of mental health treatments with its CYB003 and CYB004 programs for Major Depressive Disorder and Generalized Anxiety Disorder, respectively. The company has secured FDA Breakthrough Therapy Designation for CYB003, completed site selection for its Phase 3 study, and initiated a Phase 2 study for CYB004. These developments underscore Cybin's strong financial position, with C$209 million in cash and a successful U.S. $150 million private placement.
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Cybin Initiates Phase 3 Trial for CYB003 in Major Depressive Disorder Following Promising Phase 2 Results

Cybin has launched a Phase 3 clinical trial program, PARADIGM, to evaluate CYB003 as an adjunctive treatment for Major Depressive Disorder (MDD).
The Phase 3 program is supported by strategic partnership agreements (SPAs) with clinical sites, starting with Segal Trials, to enhance trial efficiency.

Cybin Advances Psychedelic Therapeutics for Mental Health Disorders, Eyes 2025 Milestones

Cybin Inc. highlights positive Phase 2 data for CYB003, showing significant efficacy in treating major depressive disorder (MDD).
The FDA granted Breakthrough Therapy Designation to CYB003, potentially accelerating its development for MDD treatment.

Cybin's CYB003 Shows Sustained Remission in Major Depressive Disorder After 12 Months

Cybin's CYB003, a deuterated psilocin drug, demonstrates a 71% sustained remission rate in patients with major depressive disorder (MDD) after 12 months.
The Phase 2 trial results showed a 100% response rate at 12 months following two administrations of 16 mg doses of CYB003 spaced three weeks apart.

Cybin's CYB003 Shows Sustained Efficacy in Phase 2 Depression Study

Cybin's CYB003 demonstrated a 100% response rate and 71% remission rate in MDD patients after two 16mg doses, three weeks apart.
The Phase 2 study showed sustained treatment benefits through 12 months, validating the dosing regimen and durable effects of CYB003.

Cybin's CYB003 Demonstrates Sustained Efficacy in Phase 2 Trial for Major Depressive Disorder

Cybin's CYB003 showed 100% response rate and 71% remission rate at 12 months in MDD patients after two 16mg doses, indicating long-term efficacy.
The Phase 2 study revealed a ~23-point reduction in MADRS scores at 12 months, highlighting the potential for significant and durable relief from depression.

Cybin Advances CYB003 into Phase 3 for Major Depressive Disorder

Cybin Inc. has initiated its Phase 3 PARADIGM program to evaluate CYB003 for the adjunctive treatment of Major Depressive Disorder (MDD).
The PARADIGM program includes two 12-week studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND), aiming for 550 patients.

Cybin's CYB003 Enters Phase 3 Trials for Major Depressive Disorder

Cybin has initiated its Phase 3 PARADIGM program to assess CYB003 as an adjunctive treatment for major depressive disorder (MDD).
The APPROACH study, part of the PARADIGM program, is underway and will evaluate a two-dose regimen of CYB003 against placebo, with topline results expected in 2026.

Cybin Bolsters Clinical Team as CYB003 Phase 3 Trial Nears

Cybin has expanded its clinical team to support the upcoming Phase 3 trial of CYB003 for Major Depressive Disorder (MDD).
Key appointments include Dr. Mirza Rahman as SVP, Patient Safety & Pharmacovigilance, and Dr. Marcelo Gutierrez as VP, Clinical Pharmacology.

Cybin Advances CYB003 and CYB004 Clinical Programs for Mental Health Disorders

Cybin is set to initiate a Phase 3 study of CYB003 for Major Depressive Disorder (MDD) following a productive meeting with the FDA.
Twelve-month efficacy data from the Phase 2 study of CYB003 in MDD is expected in early Q4 2024, offering insights into long-term benefits.

Cybin Inc. Advances Psychedelic Treatments for Mental Health

Cybin Inc., a clinical-stage biopharmaceutical company, is progressing in mental health treatment with psychedelic-based therapies, securing $150 million in funding and achieving FDA Breakthrough Therapy Designation for CYB003, targeting Major Depressive Disorder, with a Phase 3 study planned for mid-2024 and Phase 2 results for CYB004 for Generalized Anxiety Disorder expected in late 2024.

Reference News

[1]
Cybin Advances Mental Health Treatments
tipranks.com · Jun 26, 2024

Cybin Inc. advances mental health treatments with CYB003 and CYB004 programs, securing FDA Breakthrough Therapy for CYB0...

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