- Cybin (Cboe CA:CYBN) has begun its Phase 3 pivotal program, PARADIGM, to evaluate the efficacy and safety of CYB003 as an adjunctive treatment for Major Depressive Disorder (MDD)
- The PARADIGM program consists of three pivotal efficacy studies designed to assess CYB003’s impact on patients suffering from moderate to severe MDD who are inadequately responding to current antidepressant therapies
- Cybin also disclosed its unaudited financial results for the second quarter ending September 30, 2024, highlighting a cash position of C$154.3 million, with access to over C$217.7 million when factoring in potential warrant exercises
- Cybin (Cboe CA:CYBN) stock opened trading at C$16.50
Clinical-stage neuropsychiatry company Cybin (Cboe CA:CYBN) has begun its Phase 3 pivotal program, PARADIGM, to evaluate the efficacy and safety of CYB003 as an adjunctive treatment for Major Depressive Disorder (MDD). The program’s name reflects Cybin’s ambition for CYB003 to potentially revolutionize the treatment landscape for depression.
Overview of the PARADIGM program
The PARADIGM program consists of three pivotal efficacy studies designed to assess CYB003’s impact on patients suffering from moderate to severe MDD who are inadequately responding to current antidepressant therapies.
- Pivotal study 1 (APPROACH):
- Participants: 220, randomized 1:1 to receive either 16 mg of CYB003 or an inactive placebo.
- Dosing regimen: Two doses administered three weeks apart.
- Primary endpoint: Change in depressive symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at six weeks post-first dose.
- Sites: 36 clinical locations across the U.S. and Europe.
- Pivotal study 2 (EMBRACE):
- Participants: 330, randomized 1:1:1 to receive either 16 mg of CYB003, 8 mg of CYB003, or an inactive placebo.
- Dosing regimen: Similar to APPROACH, with doses administered three weeks apart.
- Primary endpoint: Change in MADRS scores at six weeks.
- Sites: 48 clinical locations, with minimal overlap with APPROACH.
- Pivotal Study 3 (EXTEND):
- Participants from the first two studies will roll over into EXTEND, which aims to evaluate additional doses of CYB003 for those who did not respond or relapsed during the initial studies.
All studies will employ remote, independent raters to ensure blinding and objectivity throughout the trial process.
Phase 2 results
Cybin recently reported positive results from its Phase 2 study, demonstrating robust and sustained improvements in depressive symptoms. Key findings include:
- A mean reduction of approximately 22 points in MADRS scores across both dosing cohorts.
- About 75 per cent of patients receiving 16 mg reported significant improvement, with the same percentage achieving remission (MADRS score ≤ 10).
- CYB003 was well tolerated, with no serious adverse events reported.
Managment insight
“Just three years after filing an Investigational New Drug application for CYB003, the initiation of our Phase 3 program is a truly significant and gratifying milestone,” Cybin’s CEO Doug Drysdale (pictured above) said in a news release. “Following a highly collaborative and thorough design and review process with the U.S. Food and Drug Administration, we believe that PARADIGM incorporates appropriate protocols that proactively address some of the challenges encountered by peers developing molecules with similar mechanisms of action.”
Financial update
In conjunction with the program announcement, Cybin disclosed its unaudited financial results for the second quarter ending September 30, 2024:
- Cash position: C$154.3 million, with access to over C$217.7 million when factoring in potential warrant exercises.
- Operating expenses: C$24.8 million, up from C$12.4 million year-over-year.
- Net loss: C$57.2 million, influenced by non-recurring share-based compensation.
Looking ahead
Cybin is poised for significant milestones in the coming months, including:
- 12-month efficacy data from the Phase 2 MDD study expected in Q4 2024.
- Initiation of the EMBRACE study in the first half of 2025.
With the launch of the PARADIGM program, Cybin Inc. aims to make substantial strides in the treatment of MDD, potentially offering new hope to millions affected by this challenging condition.
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 (Cboe CA:CYBN) stock opened trading up 2.68 per cent at C$16.50, but has lost 25.06 per cent since the year began.
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(Top photo via Cybin)
