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Cybin Inc
Symbol CYBN
Shares Issued 410,855,285
Close 2024-03-14 C$ 0.58
Market Cap C$ 238,296,065
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Cybin talks CYB003 phase 2 FDA meeting, phase 3 design

2024-03-14 11:30 ET - News Release

Mr. Doug Drysdale reports

CYBIN ANNOUNCES POSITIVE END-OF-PHASE 2 MEETING WITH FDA FOR CYB003 IN MAJOR DEPRESSIVE DISORDER AND PHASE 3 PROGRAM DESIGN

Cybin Inc. had a positive end-of-phase-2 meeting with the FDA (Food and Drug Administration) for CYB003, its deuterated psilocybin analog for the adjunctive treatment of major depressive disorder (MDD).

This program will be the first-ever adjunctive phase 3 deuterated psilocybin analog depression study globally and follows the successful completion of the company's phase 2 study in MDD completed at the end of 2023. The company has received minutes from its end-of-phase-2 meeting with the FDA and reached alignment on its phase 3 program design. The company intends to commence enrolment for the multinational, multisite, phase 3 program in mid-year 2024. Fifteen United States study sites have been targeted, all of which have experience running psychedelic clinical trials and are DEA (Drug Enforcement Administration) Schedule I licensed. The preliminary targeting of specific study sites will serve to expedite site initiation. The company intends to add approximately eight additional sites in Europe.

The company has engaged Worldwide Clinical Trials, a global, full-service contract research organization with deep expertise managing clinical trials for mental health conditions, including major depressive disorder. Worldwide has a record of successful patient recruitment for psychedelic trials and global relationships with best-in-class investigative sites. Worldwide has recent experience managing psychedelic studies in psychiatric populations, including clinical trials conducted in the United States, Canada, the United Kingdom and other European countries, across a range of psychedelic compounds and treatment models.

"We are very pleased with the results of our end-of-phase-2 meeting with the FDA, and appreciate the agency's thoroughness and guidance during the process. Having aligned on key features of the pivotal program, we look forward to initiating a multisite, multinational, phase 3 program around midyear," said Doug Drysdale, chief executive officer of Cybin. "The strength of CYB003's clinical profile to date, which showed that at four months after dosing, across the two doses, 60 per cent of patients receiving 12 mg [milligrams] and 75 per cent of patients receiving 16 mg of CYB003 achieved remission from depression symptoms. With positive durability data demonstrating sustained effects up to at least four months, BTD [breakthrough designation] and alignment with the FDA on our phase 3 plan, we are positioned to move quickly to progress the program, and bring relief and treatment alternatives to people who are desperately waiting," concluded Mr. Drysdale.

CYB003 phase 3 pivotal program outline

The phase 3 pivotal program will comprise two adequate and well-controlled studies, and a long-term extension, designed as follows:

  • CYB003-002 (n equals 220): Fixed, repeat-dose study of 16 mg CYB003, with two doses three weeks apart compared with two doses of placebo. The trial is designed to replicate the treatment response seen in the company's phase 2 study.
  • CYB003-003 (n equals 330): Three-arm, fixed, repeat-dose study of CYB003 (16 mg or eight mg), with two doses three weeks apart. Each active arm will be compared with two doses of placebo.
  • The primary end point of both studies is the change in MADRS (Montgomery-Asberg depression rating scale) total score from baseline at week 6, with a secondary end point at week 12, each compared with placebo.
  • Patients from each of these phase 3 trials will enroll in a one-year extension study, during which time non-responders and relapsing patients will receive one full cycle of CYB003 16 mg (two doses, three weeks apart).
  • Moderate to severe MDD patients enrolled in both studies (MADRS greater than or equal to 24) will be on stable doses of background antidepressant medication, positioning CYB003 as a convenient, adjunctive treatment option.
  • CYB003-002 is anticipated to begin around midyear 2024, with CYB003-003 anticipated to initiate a few months later. Each study is expected to run for approximately 18 months to 24 months.

Patient recruitment for the phase 3 program will include a broad MDD population, including only patients that are currently on antidepressants. Importantly, patients will not be required to titrate off their background antidepressants, which will reduce some of the inherent recruitment challenges seen in other depression studies.

Summary of positive four-month efficacy data for CYB003:

  • Robust and sustained improvements in symptoms of depression four months after two doses of 12 mg or 16 mg of CYB003:
    • Mean reduction from baseline in the MADRS total score was approximately 22 points from baseline in both dosing cohorts.
    • Approximately 75 per cent of the patients were responders (greater than or equal to 50-per-cent improvement in MADRS scores) following two doses of 16 mg.
    • 60 per cent of patients on 12 mg and 75 per cent on 16 mg were in remission from depression following two doses (MADRS score less than or equal to 10).

Safety and tolerability:

  • CYB003 was well tolerated, with no drug-related serious adverse events;
  • All adverse events were mild or moderate in intensity;
  • No incidents of suicidal ideation or behaviour;
  • No discontinuations due to adverse events.

Earlier this week, Cybin announced the granting of BTD for CYB003 by the FDA. If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.

BTD provides an expedited review pathway, as well as increased access to FDA guidance on trial design, with the potential to reduce drug development timelines. It is reserved for drug candidates that target serious conditions and demonstrate substantial improvement on a clinically significant end point over available therapies. The designation includes all fast-track program features, as well as more intensive FDA guidance and discussion of the CYB003 development program, including planned clinical trials and plans for expediting the manufacturing development strategy. CYB003 is eligible for priority review and accelerated approval.

The designation of CYB003 as a breakthrough therapy acknowledges the significant unmet medical need for more effective treatments of MDD and supports CYB003's potential for significant improvements over existing therapies.

About Cybin Inc.

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 health care is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens. Cybin is currently developing CYB003, a proprietary deuterated psilocybin analogue for the treatment of major depressive disorder, and CYB004, a proprietary deuterated DMT (N,N-dimethyltryptamine) 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.

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