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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.

Cybin Inc., a clinical-stage biopharmaceutical company, is making significant strides in mental health treatment with its psychedelic-based therapies. The company has secured a substantial $150 million in funding and achieved FDA Breakthrough Therapy Designation for its leading drug CYB003, aimed at treating Major Depressive Disorder. Anticipation is high as Cybin prepares to launch a Phase 3 study for CYB003 in mid-2024 and release Phase 2 results for another treatment, CYB004 for Generalized Anxiety Disorder, in late 2024.
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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 Psychedelic Drug for Depression Advances to Phase 3 Trial Amidst FDA Scrutiny

Cybin Inc. has received FDA approval to begin Phase 3 trials for its synthetic psilocybin variant (CYB003) to treat major depressive disorder, aiming for results in 2026.
The FDA's increased scrutiny of psychedelic drug trials, highlighted by setbacks for Lykos Pharmaceuticals and Compass Pathways, has led Cybin to incorporate more stringent safety measures.

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.

AJNA BioSciences Advances Psilocybin Antidepressant Toward FDA Approval

AJNA BioSciences is developing a standardized, full-spectrum psilocybin antidepressant aimed at meeting strict FDA guidelines for botanical drugs.
Research suggests that psilocybin-assisted therapy could benefit over five million Americans suffering from depression, highlighting a significant market opportunity.

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 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.

Reference News

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Cybin Inc. Advances Psychedelic Treatments for Mental ...
tipranks.com · May 6, 2024

Cybin Inc., a biopharmaceutical company, advances mental health treatment with psychedelic-based therapies. Secured $150...

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