Cybin Announces Positive End-of-Phase 2 Meeting with FDA for CYB003 in Major Depressive Disorder and Phase 3 Program Design
- Positive End-of-Phase 2 meeting with FDA for CYB003, a deuterated psilocybin analog for Major Depressive Disorder.
- Phase 3 program to start around mid-2024 with 15 U.S. clinical trial sites targeted.
- CYB003 demonstrates robust and sustained improvement in depression symptoms with 75% of patients in remission after two doses.
- Breakthrough Therapy Designation granted for CYB003 by FDA, providing expedited review pathway and increased engagement.
- CYB003 Phase 3 pivotal program outline includes two studies and a long-term extension, targeting moderate to severe MDD patients.
- Positive four-month efficacy data for CYB003 shows mean reduction in MADRS total score and high response rates with no serious adverse events.
- CYB003 eligible for Priority Review and Accelerated Approval, acknowledging significant unmet medical need for MDD treatments.
- None.
Insights
The announcement by Cybin Inc. regarding the positive End-of-Phase 2 meeting with the FDA for CYB003, a deuterated psilocybin analog, signals a pivotal moment in the development of psychedelic-based treatments for Major Depressive Disorder (MDD). The progression to a Phase 3 clinical trial is a critical step for Cybin, as it suggests confidence in the drug's efficacy and safety profile. The inclusion of 15 U.S. clinical trial sites and plans to add European sites demonstrates a robust and geographically diversified approach to patient recruitment, potentially enhancing the generalizability of trial results.
The Breakthrough Therapy Designation (BTD) granted to CYB003 could significantly accelerate the drug's development timeline. BTD is awarded to drugs that may offer substantial improvements over existing therapies for serious conditions, which in this case is MDD. The designation could provide Cybin with benefits such as expedited review and increased FDA engagement, potentially leading to a faster path to market. This news holds considerable weight for stakeholders, as it could presage a shorter time to revenue generation for Cybin and offer a new treatment option for patients with MDD.
The data from Cybin's Phase 2 study of CYB003 showing that 75% of patients achieved remission from depression symptoms after two doses is noteworthy, particularly as it pertains to the long-term durability of treatment effects, sustained up to four months. The design of the Phase 3 trials, with a one-year extension study, underscores the commitment to understanding the long-term efficacy and safety of CYB003. The ability to maintain patients on their existing antidepressants during the trial could reduce barriers to participation and enhance the relevance of the study outcomes to real-world clinical settings.
From a clinical research perspective, the use of the Montgomery-Åsberg Depression Rating Scale (MADRS) as a primary endpoint is a standard choice for assessing the severity of depression symptoms and the efficacy of treatment. The planned enrollment of moderate to severe MDD patients on stable doses of antidepressants positions CYB003 as an adjunctive treatment, which could address a significant gap in the current treatment landscape for MDD, where many patients do not achieve remission with existing therapies.
The safety profile of CYB003, as indicated by the absence of drug-related serious adverse events and lack of suicidal ideation or behavior, is a crucial aspect of the drug's development. The tolerability of the compound could be a differentiating factor when compared to other treatments for MDD, which often have challenging side effects that can affect patient compliance and quality of life. The emphasis on safety in the trial design, as evidenced by the detailed monitoring of adverse events, aligns with the FDA's rigorous standards for new drug approvals.
It is important to note that while the absence of serious adverse events in the Phase 2 study is promising, the Phase 3 trials will be conducted on a larger scale and over a longer period, which will provide a more comprehensive safety profile of CYB003. The commitment to a long-term extension study further illustrates the proactive approach to monitoring the safety and efficacy of CYB003 beyond the initial treatment period, which is essential for understanding the full implications of its use as a therapy for MDD.
- With
- 15 U.S. clinical trials sites targeted; European sites to be added -
- Robust and sustained improvement in depression symptoms with CYB003 at four months with
- Breakthrough Therapy Designation (“BTD”) for CYB003 provides an expedited review pathway and increased engagement with the FDA -
This news release constitutes a “designated news release” for the purposes of Cybin’s prospectus supplements each dated August 23, 2023, to its short form base shelf prospectus dated August 17, 2023, as amended December 22, 2023.
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 enrollment for the multinational, multisite Phase 3 program in mid-year 2024. Fifteen
The Company has engaged Worldwide Clinical Trials (“Worldwide”), a global, full-service contract research organization with deep expertise managing clinical trials for mental health conditions, including major depressive disorder. Worldwide has a track 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
“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 mid-year,” 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,
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=220): Fixed repeat dose study of 16mg CYB003, with two doses 3 weeks apart compared to two doses of placebo. The trial is designed to replicate the treatment response seen in the Company’s Phase 2 study.
- CYB003-003 (n=330): Three-arm fixed repeat dose study of CYB003 (16mg or 8mg), with two doses 3 weeks apart. Each active arm will be compared to two doses of placebo.
- The primary endpoint of both studies is the change in MADRS total score from baseline at Week 6, with a secondary endpoint at Week 12, each compared to 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 16mg (two doses, three weeks apart).
- Moderate to severe MDD patients enrolled in both studies (MADRS >/=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 mid-year 2024, with CYB003-003 anticipated to initiate a few months later. Each study is expected to run for approximately 18-24 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
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Robust and sustained improvements in symptoms of depression four months after two doses of 12mg or 16mg of CYB003:
- Mean reduction from baseline in the MADRS total score was approximately 22 points from baseline in both dosing cohorts.
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Approximately
75% of the patients were responders (>/=50% improvement in MADRS scores) following two doses of 16mg. -
60% of patients on 12mg and75% on 16mg were in remission from depression following 2 doses (MADRS score </= 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 behavior.
- 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 endpoint 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
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 healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.
Headquartered in
Cautionary Notes and Forward-Looking Statements
Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s planned clinical trials and program strategy for CYB003; plans for additional European study sites; the potential for CYB003 to provide significant improvement over existing therapies; the advancement of CYB003 towards a Phase 3 trial in mid-2024; the potential reduction in drug development timelines afforded by BTD; and the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the spread of COVID-19 on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in each of the Company's management's discussion and analysis for the three and nine month periods ended December 31, 2023, and the Company’s annual information form for the year ended March 31, 2023, which are available under the Company's profile on www.sedarplus.ca and with the
Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The
Neither the Cboe Canada nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.
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Investor & Media Contact:
Gabriel Fahel
Chief Legal Officer
Cybin Inc.
1-866-292-4601
irteam@cybin.com – or – media@cybin.com
Source: Cybin Inc.
FAQ
When will Cybin Inc. commence its Phase 3 program for CYB003?
What percentage of patients achieved remission from depression symptoms after two doses of CYB003?
What is the significance of Breakthrough Therapy Designation for CYB003?
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Is CYB003 well tolerated in patients according to the PR?
