Cybin has recently unveiled impressive Phase 2 clinical trial results for CYB003, a treatment based on psilocybin derivatives. The numbers are striking: after just two doses of 16 mg, 100% of participants responded positively, and 71% were in remission after 12 months, with an average reduction of 23 points on the Montgomery-Åsberg Depression Rating Scale (MADRS).
These results mark a turning point. Unlike traditional antidepressants, which require daily treatment for months and often come with side effects, CYB003 promises rapid, long-lasting effectiveness with better tolerance.
Read the full report from Cybin here.
Despite the promise, significant challenges remain. The upcoming Phase 3 trial, dubbed "PARADIGM," is a crucial step that could redefine therapeutic standards. However, methodological issues persist, particularly biases related to the placebo effect. Unlike traditional medications, the noticeable effects of psychedelics (euphoria, hallucinations) make it challenging to blind clinical trials, as participants and researchers often know whether an active treatment or placebo has been administered.
This methodological hurdle has already posed problems for competitors like Lykos Therapeutics, whose MDMA-based therapy was rejected by the FDA in June 2024, despite promising results.
Read more about Lykos’ FDA rejection here.
To address these issues, a more continuous and nuanced method of measuring depression could be key. Current tools, such as MADRS, rely on episodic questionnaires, failing to capture the day-to-day dynamics of patients’ emotional states.
This is where innovations like EMOBOT come in. Unlike traditional methods, EMOBOT offers a unique technology for passive and continuous mood and emotion tracking, providing a dynamic and precise view of treatment effectiveness.
By capturing daily emotional fluctuations, EMOBOT minimizes placebo-related biases and provides clear insights into the real effects of treatments. This real-time data could become an essential tool for clinical trials, helping to streamline and accelerate regulatory approval for groundbreaking therapies.
In France, interest in psychedelics has seen a resurgence after decades of skepticism. Initiatives like the Société Psychédélique Française, founded in 2017, and the Psi-Alc project (studying psilocybin for alcohol dependency) demonstrate growing research efforts. Researchers such as Dr. Luc Mallet and Dr. Lucie Berkovitch are actively exploring the therapeutic potential of psychedelics.
However, significant barriers remain. Bureaucratic red tape, medical conservatism, and strict regulations continue to slow the integration of psychedelics into clinical practice in France. Articles like “La France et la médecine psychédélique : une histoire compliquée” highlight the long road ahead for psychedelics in France.
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With promising clinical results, cutting-edge technologies like EMOBOT, and a growing scientific interest, psychedelics have the potential to redefine psychiatric standards. But for this revolution to succeed, methodological hurdles must be overcome, regulators must be convinced, and these advances must be integrated into safe therapeutic frameworks.
The promise of an effective, rapid, and durable treatment for depression is real. Pioneers like Cybin and innovators like EMOBOT are just beginning to uncover this potential. Are we witnessing the birth of a new paradigm in mental health care?
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Tanel Petelot is the CEO and co-founder of EMOBOT, a MedTech startup he launched in 2022 with three partners. An engineer graduate of UC Berkeley and CentraleSupélec, he is passionate about mental health and therapeutic innovation.
EMOBOT develops medical devices powered by artificial intelligence to continuously detect and monitor mood disorders, such as depression and anxiety, through passive, continuous, and multimodal symptom analysis. This solution aims to reduce the burden on doctors and overcome the limitations of current standardized tools in psychiatry.
Today, EMOBOT collaborates with around thirty hospitals across Europe, conducts multiple clinical trials, and is starting its expansion in the United States.