Numinus and Cybin Embark on a Groundbreaking Journey: Pioneering Phase 3 Trials for Major Depressive Disorder

Rhea-AI Summary

Numinus Wellness has announced its Cedar Clinical Research (CCR) site has been selected for Cybin's Phase 3 clinical trial of CYB003 for Major Depressive Disorder (MDD). The trial, set to begin enrollment mid-2024, follows promising Phase 2 results where 75% of participants achieved remission from depression symptoms. The U.S. FDA has granted breakthrough therapy designation for CYB003. The Murray, Utah location is among the 15 U.S. sites chosen for the study. Dr. Paul Thielking will lead the trial as Principal Investigator. This partnership aims to advance psychedelic-assisted therapy and address unmet needs in mental health care.

Positive

• Numinus’s Cedar Clinical Research site selected for Cybin’s Phase 3 trial.
• CYB003 Phase 2 trial results showed 75% remission from depression symptoms.
• CYB003 granted FDA breakthrough therapy designation.
• Phase 3 trial to begin enrollment in mid-2024.
• Murray, Utah location one of 15 U.S. sites for the study.
• Dr. Paul Thielking leading the trial as Principal Investigator.
• Potential significant impact on the treatment of Major Depressive Disorder.
• Collaboration underscores Numinus's commitment to innovative mental health treatments.

Negative

• No new revenue or financial gains reported from the collaboration.
• The trial is in early stages; results and approval are not guaranteed.
• Potential shareholder dilution if additional funding is needed for trials.
• Increased expenses associated with conducting the trial.

Vancouver, British Columbia--(Newsfile Corp. - May 30, 2024) - In a significant stride towards transforming mental health care, Numinus Wellness Inc. (TSX: NUMI) (OTCQX: NUMIF) (FSE: LR23) has proudly announced that its research site, Cedar Clinical Research (CCR), has been selected for Cybin's Phase 3 pivotal multinational clinical trial of CYB003. Aimed at revolutionizing the treatment of Major Depressive Disorder (MDD), this collaboration marks a pivotal moment in the journey toward understanding and treating one of the most debilitating mental health conditions affecting over 20 million Americans.

The choice of CCR as a trial site underscores Numinus's commitment to advancing traditional and innovative behavioral health treatments. It is a testament to the company's dedication to fostering safe, evidence-based novel therapies that have the potential to significantly impact patient care. CCR's Murray, Utah location will be one of the 15 U.S. sites chosen for this groundbreaking study.

Cybin's Phase 2 trial results, where 75% of participants achieved remission from depression symptoms four months after dosing with CYB003, not only showcased the compound's promising impact, but also led to the U.S. Food and Drug Administration (FDA) granting it breakthrough therapy designation.

The Phase 3 trial, set to begin enrollment in mid-2024, will delve deeper into CYB003's safety and efficacy. Under the leadership of Dr. Paul Thielking, Numinus's Chief Science Officer and the trial's Principal Investigator, the study aims to further explore CYB003's potential to address a critical unmet need in mental health care.

Dr. Thielking's enthusiasm for the project is palpable, "The Phase 2 results from the CYB003 trials were impressive and demonstrated the potential for treating a serious condition that affects over 20 million Americans. We look forward to working with Cybin on the Phase 3 trials to add to the knowledge of CYB003's efficacy and address an important unmet need in patient care."

Payton Nyquvest, Numinus Founder and CEO, echoed this sentiment, highlighting 2024 as a pivotal year for psychedelic-assisted therapy. "We are proud of our role in working with drug developers to facilitate the important research that will help move these candidates to FDA approval and ultimately patient care."

This partnership between Numinus and Cybin, both leading figures in the psychedelic-assisted therapy space, is not just a milestone in clinical research; it represents a beacon of hope for millions struggling with MDD. It shines light on a shared vision for a future where depression and other mental health conditions are not just managed but substantially healed.

As the trial progresses, Numinus and Cybin remain committed to transparently sharing their findings and continuing their dedicated pursuit of novel, impactful solutions for mental health care, aiming to not only shortens the drug development timeline but also paves the way for CYB003 to become a potential first-of-its-kind adjunctive psychedelic-based therapeutic for MDD.

For individuals and families affected by MDD, the initiation of this trial is a significant and hopeful development. It heralds a future where the darkness of depression can be lifted through innovative, evidence-based treatments that promise not just relief but true healing.

In taking on this pivotal trial, Numinus and Cybin are not just conducting research; they're crafting a new narrative for mental health treatment-one where innovation, care, and hope converge to offer new beginnings.

To learn more about the CYB003 Phase 3 trial and the transformative work being done by Numinus Wellness Inc., visit their website and follow their progress on social media. This journey represents not just scientific advancement, but a stride towards compassion, understanding, and holistic care in mental health.

Numinus
payton@numinus.com
Payton Nyquvest

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/210775

FAQ

What is the focus of Numinus and Cybin's Phase 3 trial?

The focus is on testing the safety and efficacy of CYB003 for treating Major Depressive Disorder (MDD).

When will the enrollment for Cybin's Phase 3 trial begin?

Enrollment for the Phase 3 trial is set to begin in mid-2024.

What were the results of Cybin's Phase 2 trial for CYB003?

The Phase 2 trial showed that 75% of participants achieved remission from depression symptoms four months after dosing.

Which regulatory body granted breakthrough therapy designation to CYB003?

The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to CYB003.

Where is one of the locations selected for Cybin's Phase 3 trial?

One of the selected locations is Cedar Clinical Research in Murray, Utah.

Who is the Principal Investigator for the Phase 3 trial?

Dr. Paul Thielking is the Principal Investigator for Cybin's Phase 3 trial.

What is the potential benefit of CYB003 for patients?

CYB003 has the potential to significantly impact the treatment of Major Depressive Disorder by achieving high remission rates.