How Cybin aims to maximize the potential of two classical psychedelics 

Classical psychedelics can be agents of chaos. In sufficient doses, they can trigger experiences of ego death or dissolution, as researchers have noted since the 1960s. Psychedelics can also help promote neural plasticity and uproot negative patterns to treat challenging-to-treat mental health disorders. FDA has acknowledged the potential of psilocybin for mental health by twice granting Breakthrough Therapy Designation status to the compound as a potential therapy for serious depression. 

The startup Cybin (Toronto, Canada) aims to harness the therapeutic potential of psychedelics while minimizing possible adverse side effects. 

Cybin’s deuterated psilocybin analog CYB003 could treat major depressive disorder (MDD) and alcohol use disorder (AUD) while potentially being better tolerated than traditional psilocybin. 

CYB003 is the company’s first focus as psilocybin is the most studied psychedelic molecule in academic studies “with decad…

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How psychedelics could address unmet need in mental health

[Image courtesy of Pixabay]Interest in the therapeutic potential of psychedelics is booming, given their therapeutic potential for treating depression and other conditions. It is telling that psychedelics were among the hottest topics at the World Economic Forum (WEF) meeting this year in Davos, Switzerland, prompting mockery from late-night comics. 

Although the field remains embryonic, part of the reason for the recent interest in psychedelics is their potential to address difficult-to-treat mental health conditions. 

Get the full story from our sister site, Drug Discovery & Development. 

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How psychedelics could address unmet need in mental health

[Image courtesy of Pixabay]

Interest in the therapeutic potential of psychedelics is booming, given their therapeutic potential for treating depression and other conditions. It is telling that psychedelics were among the hottest topics at the World Economic Forum (WEF) meeting this year in Davos, Switzerland, prompting mockery from late-night comics. 

Although the field remains embryonic, part of the reason for the recent interest in psychedelics is their potential to address difficult-to-treat mental health conditions. For example, research such as the U.S. government-backed Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study “showed us that our available medications are not as effective as we’d hoped they would be,” said Dr. John Krystal, chair of the department of psychiatry at Yale University, in a recent webinar from Cybin (Toronto, Canada). For depressed who respond to s…

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Cybin files IND with FDA for early human study focused on major depressive disorder

The biopharma Cybin Inc. (NYSEAMERICAN:CYBN) has filed a submission of an Investigational New Drug (IND) application with the FDA for its Phase 1/2a first-in-human clinical trial focused on CYB003.

CYB003 is a proprietary psilocybin analog as a proposed treatment of major depressive disorder (MDD) as an adjunct to psychotherapy.

The study would enroll approximately 40 patients, according to a description on ClinicalTrials.gov. The trials would focus on studying the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of CYB003 in patients with MDD.

The proposed study would use the Montgomery-Asberg Depression Rating Scale to gauge improvements in mood and other parameters.

Psilocybin has received a growing amount of interest in recent years. The compound is the focus of more than 50 studies, including Phase 2 studies focused on depressive and post-traumatic stress disorders.

Cybin is also investigating the potential of …

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As interest in psychedelic medicine grows, Big Pharma sits on the sidelines

Image by Ben Johnson from Pixabay

While Big Pharma has yet to embrace psychedelics as potential treatments for depression and other psychiatric disorders, interest in psychedelic medicine is building. 

Earlier this month, Nature Medicine published a Phase 3 study indicating that psychotherapy assisted with methyl​enedioxy​methamphetamine (MDMA) was a more effective treatment for post-traumatic stress disorder (PTSD) than therapy alone. The study authors concluded that MDMA yielded a larger effect size than antidepressants Zoloft (sertraline) and Paxil (paroxetine).

The FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD in 2017. Approval could come in 2023, according to The New York Times. 

[Related: Debate series considers the therapeutic promise and pitfalls of psychedelics]

Last month, NEJM summarized the results of a Phase 2 study that found that psil…

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