Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive Disorder
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Hello Everyone,
The buzz continues to rise over psychedelics. There has been a resurgence of interest in psychedelic compounds based on studies demonstrating their potential therapeutic applications in treating post-traumatic stress disorder, substance abuse disorders, and treatment-resistant depression.
The U.S. psychedelics industry is growing with heavy private investment and even with the blessing of the chief U.S. drug-approval agency!
It was last June that the U.S. Food and Drug Administration issued its first-ever draft guidance on psychedelic drug clinical trials in key areas like psychedelic therapy and high-end herbal medicine, providing industry companies with a glimpse at a regulatory roadmap for drug development.
In addition, the psychedelic drugs market is expected to grow from $4.9 billion in 2022 to $11.8 billion by 2029, says U.K.-based Brandessence Market Research. That’s a compound annual growth rate of about 13.5%!
Wall Street has some hidden gems hiding in this growing arena. This includes Cybin, Inc. which trades under the symbol “CYBN”.
CYBN 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.
The company is revolutionizing mental healthcare and 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.
This one has had two key pieces of news in the past few days. You can see on the 10 day chat above that the market certainly reacted.
Can psychedelic drugs, once banned, help relieve mental illness? Many say yes.
Decades after most hallucinogens were outlawed, researchers are now using them to treat disorders like PTSD, depression, and addiction.
What is CYBN doing?
Cybin is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary dDMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.
Positive Data Released…
CYBN reported positive Phase 2 topline results for CYB003, its proprietary deuterated psilocybin analog in development for the adjunctive treatment of Major Depressive Disorder (“MDD”), demonstrating a 79% remission rate from depression –
The company also announced positive topline results from Phase 1 studies of proprietary deuterated dimethyltryptamine (“dDMT”) molecules CYB004 and SPL028, supporting clinical advancement and the successful development of an intramuscular (“IM”) formulation.
New Patents!
CYBN has also strengthened its patent portfolio with the addition of 6 new patents in key jurisdictions.
“During the past three months, we have continued to make exciting progress with positive topline data from our CYB003 and DMT programs,” said Doug Drysdale, Chief Executive Officer of Cybin.
“The data collected from our clinical trials forms the foundation of our next set of value-creating milestones, as we advance our key programs this year. For CYB003, the three-month Phase 2 efficacy data is expected in Q1 and will provide insights into the durability of treatment effect in MDD. Promising outcomes, such as a 79% remission from depression at 6 weeks in our Phase 2 CYB003 trial, and important safety and dosing findings in our Phase 1 dDMT studies, validate our path forward. Plans are underway to initiate a Phase 3 multisite trial of CYB003 for MDD, and with FDA clearance, we are progressing to a Phase 2a study of CYB004 for the treatment of GAD. We are proud of the rapid progress we have made and look forward to the important work ahead of us. We are encouraged by the positive findings across our clinical-stage programs to date and believe we are well on our way to providing more effective and patient-friendly treatment alternatives for a multitude of mental health disorders,” concluded Drysdale.
Cybin Announces Positive End-of-Phase 2 Meeting with FDA for CYB003 in Major Depressive Disorder and Phase 3 Program Design
– With U.S. Food and Drug Administration (“FDA”) alignment on multisite, multinational Phase 3 program design Company expects to commence Phase 3 program around mid-year 2024 –
– 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 75% of patients in remission from depression after two doses (16mg) –
– 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.
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced a positive End-of-Phase 2 meeting with the FDA 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 enrollment for the multinational, multisite Phase 3 program in mid-year 2024. Fifteen U.S. study sites have been targeted, all of which have experience running psychedelic clinical trials and are DEA Schedule I licensed. The preliminary targeting of specific study sites will serve to expedite site initiation. The Company intends to add approximately 8 additional sites in Europe.
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 U.S., Canada, 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 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, 60% of patients receiving 12mg and 75% of patients receiving 16mg of CYB003 achieved remission from depression symptoms. With positive durability data demonstrating sustained effects up to at least four months, BTD, 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 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=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
- 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.
- Approximately 75% of the patients were responders (>/= 50% improvement in MADRS scores) following two doses of 16mg.
- 60% of patients on 12mg and 75% on 16mg were in remission from depression following 2 doses (MADRS score
Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive Disorder
– Breakthrough Therapy Designation (“BTD”) provides an expedited review pathway, as well as increased access to U.S. Food and Drug Administration(“FDA”) guidance on trial design, with the potential to significantly reduce drug development timelines –
– First known BTD granted by the FDA for an adjunctive psychedelic based therapy for the treatment of Major Depressive Disorder (“MDD”) –
– Robust, sustained and statistically significant improvement in depression symptoms at four months with 75% of patients in remission from depression after two doses (16mg) –
– Impressive mean 22-point reduction in Montgomery-Asberg Depression Rating Scale (“MADRS”) score from baseline at four months –
– Data supports progression to a pivotal Phase 3 multinational study of CYB003 in MDD in mid-2024 –
– Achievement of milestones expedites and de-risks CYB003 development program –
– Company to host webcast to discuss CYB003 program updates today at 8:30 a.m. ET –
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.
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced that the FDA has granted BTD to CYB003, its proprietary deuterated psilocybin analog in development for the adjunctive treatment of MDD. If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.
Strong and durable effects 4 months after 2 doses (Graphic: Business Wire)
The Company also announced that its Phase 2 trial of CYB003 in MDD demonstrated robust and sustained improvement in depression symptoms at four months with 75% of participants receiving two 16mg doses achieving remission and no longer showing signs of depression.
These significant milestones reflect the Company’s commitment to advancing cutting-edge treatment options for MDD, marking a transformational moment in the pursuit of regulatory approval.
Breakthrough Therapy Designation Accelerates and De-risks the Path Forward6
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.
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. BTD serves as validation of the Company’s progress to date and is expected to accelerate Cybin’s mission to advance its proprietary next-generation treatment towards new drug approval on an expedited basis.
This designation is supported by the positive topline results from the Company’s Phase 2 study of CYB003 in MDD, which demonstrated an improvement in depression symptoms superior to approved antidepressants and recently reported data with other psychedelics.1
“It is a testament to the hard work and dedication of the entire Cybin team that we have accomplished so much so quickly. The granting of Breakthrough Therapy Designation by the FDA underscores the potential of CYB003 to fill a gap in the treatment landscape for MDD and serves to expedite and de-risk our development program going forward,” stated Doug Drysdale, Chief Executive Officer of Cybin. “This designation provides for a streamlined review process and enhanced engagement with the FDA. With the robust durability data from our Phase 2 study in hand, we are ready to move forward expeditiously. We are grateful for the opportunity to accelerate the development and regulatory review process that this designation affords, as we prepare to advance CYB003 toward a Phase 3 pivotal trial around mid-year.”
“Currently available standard treatments for MDD can be limited in efficacy, remission and response rates, presenting challenges for patients and mental health practitioners alike. CYB003 may have potential to address these challenges, and with the FDA’s Breakthrough Therapy Designation, the regulatory path forward is accelerated,” said Dr. Maurizio Fava, M.D., Chair of the Department of Psychiatry and Psychiatrist-in-Chief at Massachusetts General Hospital.
Positive Four-Month Efficacy Data for CYB003
- Robust and sustained improvements in symptoms of depression with 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% of the patients were responders (>/= 50% improvement in MADRS scores) following two doses of 16mg.
- 60% of patients on 12 mg and 75% on 16 mg were in remission from depression following 2 doses (MADRS score
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