2024-03-13 07:29:10 ET
DENVER, Colo., Mar 13, 2024 ( 247marketnews.com )- Cybin Inc. (NYSE: CYBN ) announced, this morning, that the FDA granted Breakthrough Therapy Designation to CYB003, its proprietary deuterated psilocybin analog in development for the adjunctive treatment of Major Depressive Disorder. If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based Major Depressive Disorder therapeutic.
The Company also reported that its Phase 2 CYB003 trial 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.
“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.
“The sustained reduction in depression symptoms at the four-month mark after just two doses of CYB003 is a critical milestone, that demonstrates the durability of the response, following the rapid improvement in symptoms. It also paves the way for a change in the treatment paradigm for MDD. Unlike currently approved adjunctive treatments which require chronic, daily dosing, CYB003 allows for intermittent dosing without the challenges of withdrawing patients from their existing medications,” stated Amir Inamdar, MBBS, DNB (Psych), MFPM, Chief Medical Officer of Cybin. “Notably, the durability data showed that at four months, approximately 75% of patients were responders, meaning that they achieved an improvement of 50% or greater in their MADRS scores. Across the two dosages, we also observed that at four months, 60% of patients receiving 12 mg and 75% receiving 16 mg achieved a MADRS score of less than or equal to 10, indicating that they were in remission and no longer showing signs of depression. Considering these positive findings, we are eager to progress the program and bring relief and treatment alternatives to the millions of people who can benefit,” concluded Mr. Inamdar.
“It is truly remarkable that at four months the participants experienced a sustained reduction and incremental improvement in depression symptoms,” continued Drysdale. “Impressively, the mean reduction from baseline in the MADRS total score was approximately 22 points at 4 months (compared to a mean reduction of 14 points vs placebo and 17 points from baseline at 3 weeks). This is highly encouraging, especially for patients who have not responded to existing treatment options. We look forward to initiating our Phase 3 trial, which we anticipate will be an international, multisite study to further evaluate the safety and efficacy of CYB003 capsules in a larger MDD patient population. As we advance this program, we are proud to lead the way and contribute to the growing body of scientific evidence supporting the therapeutic potential of psychedelic drugs to treat a multitude of mental health disorders,” concluded Drysdale.
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Cybin’s Novel Psychedelic Molecule CYB003 Receives FDA Breakthrough Therapy Designation and Positive Phase II Data