Press Release: Beckley Psytech receives FDA Investigational New Drug (IND) approval for Phase IIb study of BPL-003, a novel synthetic formulation of 5-MeO-DMT (Mebufotenin)
OXFORD, England–(BUSINESS WIRE)–Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into safe, effective and licensed medicines, today announced that it had received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for a global multi-site Phase IIb study exploring the safety, efficacy and tolerability of two distinct doses of its lead compound, BPL–003, in patients with Treatment Resistant Depression (TRD).
BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device. This IND marks the first time the FDA has ever given IND approval for a Phase IIb study of a short-acting psychedelic treatment or a 5-MeO-DMT treatment. The study will be conducted with the help of 40 investigator sites in 7 different countries and is due to be initiated in H1 2023.
Phase I datahas already shown BPL-003 to be well-tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile. Medium and high dosages were found to reliably induce profound psychedelic experiences, which might be correlated with positive clinical outcomes, with a rapid onset of psychedelic treatment effects within minutes. All perceptual effects were resolved within 60-90 minutes.
Beckley Psytech’s Phase IIb randomised, dose-finding study will evaluate the effects of a single medium or high dose of BPL-003 against a sub-perceptual dose in patients with moderate to severe TRD who are not taking concomitant antidepressants. The study will be quadruply masked, with the patient, investigator, attendant and outcomes assessor all blinded to the dose allocation of the subject to reduce expectancy bias. Efficacy will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) at several time points during the trial.
The Phase IIb study, which is fully funded from Beckley Psytech’s existing cash reserves, will complement the Company’s ongoingPhase IIa study of BPL-003 for TRDand initial results are expected in 2024.
Commenting on the IND approval, Cosmo Feilding Mellen, Chief Executive Officer at Beckley Psytech, said:“This is a critical step towards our mission of delivering safe, effective and licensed psychedelic treatments to patients in need, and is also a significant milestone in the evolution of our clinical pipeline. It’s a privilege to be given the FDA’s first IND for a Phase IIb study of 5-MeO-DMT and it provides firm validation of the positive preclinical and Phase I data we have generated so far with BPL-003. This is an important step not only for Beckley Psytech, but also for the whole field of psychedelic drug development and, most importantly, for patients who are in urgent need of more effective treatments for mental health conditions such as depression.”
It is estimated that nearly300 million peoplearound the globe have depression but, for many of those living with the condition, even the best current medicines either do not work or have side effects that leave them unable to experience life to the fullest.33% of patients are resistant to available treatments, such as selective serotonin reuptake inhibitors (SSRIs), and60% of patientsdiscontinue or switch SSRIs within 12 weeks due to side effects.
Beckley Psytech’s Chief Medical Officer, Dr Frank Wiegand, also said:“The distinctive characteristics of BPL-003 make us optimistic about the compound’s potential to be a safe and effective alternative to currently available antidepressants. The rapid onset of effect, as well as the reliable induction and short duration of profound psychedelic experiences, are of great interest to us and we are excited to assess the therapeutic benefits of BPL-003 more deeply in this study”.
Psychedelics are experiencing a resurgence in the field of mental health care. Once relegated to the fringes of both medical practice and legality, compounds such as psilocybin, MDMA, LSD, and ketamine are now being re-examined for their therapeutic potential. A recent survey reveals that a significant portion of mental health professionals are open to incorporating psychedelic-assisted therapy into their practices—on the condition that these treatments are legalized and regulated. This shift in attitude reflects both growing scientific evidence for psychedelics’ efficacy and increasing awareness of their ability to address treatment-resistant conditions like depression, anxiety, and PTSD.
Psychedelic Therapy: A Re-Emerging Field
In recent years, research on psychedelics has surged, leading to promising results in the treatment of mental health conditions that often prove resistant to conventional therapies. The Multidisciplinary Association for Psychedelic Studies (MAPS) and other research institutions have been conducting clinical trials on substances like MDMA for PTSD, psilocybin for depression, and ketamine for treatment-resistant depression and suicidal ideation. These studies demonstrate that psychedelic substances, when combined with psychotherapy, offer rapid and sustained relief from symptoms with minimal side effects when administered in controlled environments.
A surveyconducted among mental health professionals, including psychiatrists, psychologists, counselors, and social workers, has provided valuable insight into their perspectives on psychedelic therapies. While many respondents expressed enthusiasm about the potential of psychedelics, the key barriers identified were the current legal status and regulatory uncertainty surrounding these substances.
Survey Results: Mental Health Professionals Support Psychedelics Under Regulation
The survey revealed that 69% of respondents were willing to use or recommend psychedelic-assisted therapy for their patients if it became legal in their jurisdiction. Mental health professionals are particularly interested in the use of psychedelics for treatment-resistant conditions, such as major depressive disorder (MDD) and PTSD, where traditional treatments have often been insufficient.
Despite this enthusiasm, concerns remain about the need for proper regulation and oversight. Professionals emphasized that legal frameworks would need to ensure that psychedelic therapies are delivered safely and effectively, with clear guidelines for dosing, set and setting, and professional training. There is also a push for psychedelic therapists to receive specialized education, much like those working in other areas of pharmacological therapy.
Legal and Ethical Considerations
Currently, most psychedelics remain classified as Schedule I substances in the United States under the Controlled Substances Act, meaning they are considered to have no accepted medical use and a high potential for abuse. This legal status poses a significant barrier to their use in clinical settings, despite mounting evidence to the contrary.
In regions where decriminalization or medical use of psychedelics has gained momentum, such as Oregon and Colorado, psychedelic therapy is slowly becoming more accepted. Oregon, for instance, was the first state to legalize the supervised therapeutic use of psilocybin in 2020. Meanwhile, several cities, including Denver and Oakland, have decriminalized the possession of psilocybin and other entheogenic plants. These local efforts highlight a growing recognition that psychedelics, when used responsibly and within the right context, can provide healing opportunities for individuals who have exhausted traditional treatment methods.
However, mental health professionals have raised concerns about the ethical implications of widespread psychedelic use. They stress the need for stringent training requirements for therapists, particularly because psychedelic experiences can induce profound and sometimes overwhelming emotional responses. In therapeutic contexts, these experiences need to be properly integrated into a patient’s broader psychological framework, requiring both expertise and ethical responsibility.
Scientific Evidence Behind Psychedelic Therapies
The growing interest in psychedelic-assisted therapy is not simply a matter of changing societal attitudes—scientific research increasingly supports its efficacy. Some of the most promising results come from studies on psilocybin and MDMA.
Psilocybin and Depression: Psilocybin, the active compound in magic mushrooms, has shown significant potential in treating depression, including treatment-resistant depression. A study published in JAMA Psychiatry demonstrated that two doses of psilocybin, combined with supportive psychotherapy, reduced depressive symptoms in patients for up to a year. Many participants reported a profound sense of emotional clarity and connectedness, which allowed them to process deeply ingrained feelings of sadness and despair.
MDMA for PTSD: One of the most well-known psychedelic therapies is MDMA-assisted therapy for PTSD. Clinical trials led by MAPS have shown that MDMA, when administered in a therapeutic setting, helps patients with PTSD by lowering the emotional intensity of traumatic memories, making it easier for them to process these experiences. In Phase 3 trials, over 60% of participants no longer met the diagnostic criteria for PTSD after just three sessions of MDMA-assisted therapy.
Ketamine: Already approved for clinical use as esketamine, ketamine has gained attention for its rapid-acting antidepressant effects. When used in low doses under medical supervision, ketamine can rapidly alleviate symptoms of treatment-resistant depression and suicidal ideation, providing relief within hours or days, compared to the weeks or months it takes for traditional antidepressants to take effect.
Training and Certification: A Key Concern
One of the most consistent points raised in the survey is the importance of ensuring that mental health professionals are adequately trained to administer psychedelic therapies. Given the profound psychological effects that psychedelics can induce, therapists need specialized training in both the administration of these substances and the integration of the experiences that arise during therapy sessions.
Many professionals also argue for the creation of certification programs that would establish clear standards for psychedelic therapy. These certifications would ideally cover:
Dosing protocols
Managing difficult or overwhelming experiences (often called “bad trips”)
Psychological preparation and integration techniques
Safety measures for vulnerable populations, such as those with a history of psychosis or bipolar disorder
Without proper training, the risks of psychedelic therapy, including re-traumatization or psychological destabilization, could outweigh the benefits, particularly in cases of complex trauma or severe mental health disorders.
The Future of Psychedelic-Assisted Therapy
As the legal and regulatory landscape around psychedelics continues to evolve, it is clear that the mental health field is preparing for the potential widespread adoption of psychedelic therapies. The survey’s findings indicate that the majority of mental health professionals are open to the integration of psychedelics, particularly if legal barriers are removed and appropriate safety measures are put in place.
The future of psychedelic therapy will likely involve a blend of clinical trials, regulatory changes, and public education about both the risks and benefits of these treatments. Mental health professionals will play a critical role in shaping how these therapies are implemented, ensuring that they are used ethically and effectively in clinical settings.
If legalized, psychedelics could mark a paradigm shift in mental health care, offering new hope for individuals suffering from anxiety, depression, PTSD, and other psychiatric conditions that have proven difficult to treat with conventional methods.
Conclusion
The survey of mental health professionals provides a glimpse into the future of psychedelic-assisted therapy. The openness of clinicians to these treatments, contingent upon legalization, suggests a broader acceptance of psychedelics as viable therapeutic tools. As research continues to support the safety and efficacy of psychedelics for treating mental health disorders, the field is poised for significant changes. The next few years may see these once-controversial substances become part of mainstream psychiatric treatment, revolutionizing how conditions like PTSD, depression, and anxiety are managed.
Sources
Sermo Barometer Survey: 94% of Global Mental Health Professionals Open to Psychedelic Treatments. Business Wire, 2024.
Moliner, R. et al., “Psychedelic treatments are speeding towards approval,” Nature, 2023.
How Psychedelic Treatment Can Revolutionise Mental Health. Health Europa, 2024.
Lewis, C. R. et al., “MDMA and PTSD: Clinical Applications,” Frontiers in Psychiatry, 2023. DOI: (Nature).
Sam Altman, the CEO of OpenAI, recently shared how a weekend retreat in Mexico, where he participated in a guided psychedelic session, changed his life. During this retreat, he ingested psilocybin, the psychoactive compound found in magic mushrooms, and experienced profound emotional breakthroughs that altered his perspective on both his personal and professional life. Sam Altman’s openness about his psilocybin retreat reflects a growing trend of prominent figures exploring the therapeutic potential of psychedelics for personal growth and mental health healing.
Sam Altman’s Psilocybin Journey: How a Mexico Retreat Transformed His Life
Psilocybin: The Compound Behind Altman’s Transformation
Psilocybin has a long history of use in indigenous cultures, particularly in regions like Mexico, where it has been employed in spiritual and healing ceremonies for centuries. It is a psychedelic substance that, once ingested, converts to psilocin in the body, which interacts with the brain’s serotonin receptors, altering perception, mood, and cognition. Psilocybin has been at the forefront of the psychedelic renaissance, where both clinical trials and personal accounts like Altman’s highlight its potential to treat various mental health issues, such as depression, anxiety, and PTSD.
A Deeper Dive Into Psychedelic Retreats
Altman’s experience took place in a structured psilocybin retreat setting in Mexico, a country that has emerged as a popular destination for such experiences due to its relatively lenient legal framework around psychedelics. Retreat centers in Mexico often combine traditional healing practices with modern therapeutic approaches, offering participants an immersive and supportive environment to explore their inner worlds. The retreats are facilitated by experts in both plant medicine and mental health, ensuring that the process is safe and beneficial.
These retreats typically include guided sessions, where participants consume psychedelics in a controlled environment, often accompanied by meditation, music, and sensory experiences that enhance the journey. For many, the experience leads to ego dissolution, a state where the sense of self fades, often resulting in a greater sense of connectedness to others and the world around them. Altman’s encounter with psilocybin allowed him to gain new insights into his emotional life and work responsibilities, echoing the experiences of many who have undergone psychedelic-assisted therapy.
Scientific Research: Psilocybin’s Role in Mental Health
Research on psilocybin has grown exponentially over the past decade. Leading universities like Johns Hopkins and Imperial College London have conducted clinical trials demonstrating psilocybin’s effectiveness in treating treatment-resistant depression, end-of-life anxiety, and even addiction. One study at Johns Hopkins revealed that a single high-dose session of psilocybin, when combined with psychotherapy, produced a lasting reduction in depressive symptoms, with participants reporting benefits up to six months after the session.
The mechanism behind psilocybin’s success is its ability to increase neuroplasticity, which allows the brain to form new connections and break free from rigid patterns of thought—one of the hallmarks of mental health disorders like depression. This altered brain state, coupled with the powerful emotional experiences that often accompany psilocybin use, helps patients process trauma, grief, and existential anxiety in ways that traditional therapies may not be able to achieve.
Psilocybin’s Impact Beyond Therapy: Personal Growth and Creativity
Beyond its therapeutic uses, psilocybin has gained attention for its ability to foster personal growth, creativity, and problem-solving skills. Silicon Valley executives and creatives alike have explored psychedelics as tools for enhancing creativity and breaking free from habitual thought patterns. Altman’s experience adds to the growing anecdotal evidence suggesting that psychedelics can unlock new perspectives on life challenges, relationships, and professional dilemmas. His participation in the psilocybin retreat not only deepened his emotional understanding but also allowed him to reflect more clearly on complex decisions related to his role at OpenAI.
Mexico’s Role in the Psychedelic Renaissance
Mexico’s role as a hub for psychedelic retreats is partly due to the country’s rich tradition of plant medicine and its more relaxed attitude toward certain psychedelics compared to the United States. In regions like Oaxaca, Mazatec communities have long used psilocybin mushrooms for ceremonial purposes. This ancient practice has blended with modern wellness tourism, as individuals from around the world seek healing and spiritual exploration in these culturally immersive retreats.
As more people travel to Mexico for psilocybin retreats, the demand for safe and professional experiences has led to the development of well-structured programs that include integration support—guidance on how to apply the insights gained during the psychedelic experience to everyday life. This integration is crucial, as it ensures that the deep emotional and psychological breakthroughs experienced during a session lead to long-lasting changes in behavior and outlook.
The Future of Psychedelic-Assisted Therapy
Altman’s openness about his psychedelic experience comes at a time when psychedelics are gaining mainstream attention. Several U.S. cities and states have decriminalized or legalized psilocybin for therapeutic use, including Oregon, which became the first state to legalize psilocybin therapy in 2020. As more public figures and entrepreneurs embrace the potential of these substances, the cultural stigma surrounding psychedelics is slowly eroding.
In the coming years, experts predict that psilocybin therapy will become a widely accepted treatment for a range of mental health conditions, especially as ongoing research continues to validate its efficacy. The FDA has already granted breakthrough therapy status to psilocybin for its ability to treat major depression, paving the way for potential federal legalization in the future.
Conclusion: A Life-Changing Experience with Far-Reaching Implications
Sam Altman’s transformative weekend retreat in Mexico underscores the growing interest in psychedelic therapies among high-profile individuals seeking not only emotional healing but also personal and professional insights. His story reflects the broader psychedelic renaissance, where plant medicines like psilocybin are being recognized for their powerful effects on mental health, creativity, and self-awareness. As research continues to explore the potential of psychedelics, their role in modern therapy and wellness is set to expand, potentially revolutionizing how we approach mental health and personal growth.
On September 18, 2024, the UK launched its first-ever psychedelic trade association, Psychedelic Industry UK (PsyIndUK), marking a pivotal moment in the country’s psychedelic medicine sector. As psychedelic-assisted therapies gain recognition for their potential to treat mental health conditions like depression, PTSD, and addiction, PsyIndUK aims to unify and advance the UK’s psychedelic industry by fostering collaboration, promoting research, and engaging with policymakers and regulators.
What is PsyIndUK?
Led by James Bunn, a prominent regulatory expert in the field of psychedelics, PsyIndUKbrings together key stakeholders from across the UK’s psychedelic sector. The organization’s mission is to drive forward evidence-based, sustainable, and equitable growth of the psychedelic medicine industry. By working with scientific researchers, healthcare professionals, and regulatory bodies, PsyIndUK seeks to ensure that the development of psychedelics is conducted responsibly and safely.
Why the Launch of PsyIndUK is Important
The launch of PsyIndUK comes at a crucial time. Although 2024 has seen promising developments in psychedelic research, it has also been marked by challenges, including overpromising and delays in regulatory approvals for psychedelic treatments. PsyIndUK aims to address these challenges by creating a unified voice for the industry, helping to streamline the development of therapeutic psychedelics like psilocybin, MDMA, DMT, LSD, and ketamine.
PsyIndUK’s core mission is to guide the scientific and clinical development of these substances while ensuring that regulations protect patient safety. The association will advocate for professional training in psychedelic-assisted therapy, ensuring that healthcare providers are adequately prepared to deliver these treatments in clinical settings.
Psychedelic Industry UK Chair Dr Rayyan Zafar added: “PsyIndUK is committed to rigorous scientific and medical research to guide therapeutic delivery, professional training for healthcare providers, and regulations to protect patient safety. We look forward to working across the sector to achieve this.”
Key Members and Founding Partners
The founding members of PsyIndUK represent some of the leading players in the UK’s psychedelic landscape, including organizations like Heroic Hearts, PsyAware, Psilonautica, and Volteface. The organization is open to a broad range of companies and institutions, providing them with access to working groups, networking events, and opportunities to influence policy.
The founding members of PsyIndUK are as follows:
Heroic Hearts
Onaya
Psilonautica
PsyAware
Psych
Psychedelic Health
PsyEdu
Shortwave Life Sciences
Volteface
Collaborating for a Holistic Approach
PsyIndUK emphasizes a holistic approach to the development of psychedelic therapies. This means focusing on the whole ecosystem of the industry, from clinical trials to the eventual regulatory frameworks that will govern the use of these substances in medicine. With the growing body of research supporting the efficacy of psychedelic treatments, PsyIndUK is committed to ensuring that these therapies are introduced safely and scientifically validated.
Global Context and Implications
The formation of PsyIndUK is part of a larger global trend toward integrating psychedelic therapies into mainstream healthcare. Countries such as the U.S., Canada, and Australia are also expanding research into psychedelics, and regulatory bodies worldwide are beginning to explore frameworks that could see psychedelics used to treat a range of mental health disorders.
By establishing a unified organization, the UK has positioned itself as a leader in the global conversation on psychedelics. The success of PsyIndUK could serve as a model for other countries looking to regulate and support their burgeoning psychedelic sectors.
Conclusion: A New Era for Psychedelic Medicine in the UK
The launch of PsyIndUK marks a critical step toward creating a sustainable and regulated psychedelic industry in the UK. By fostering collaboration, promoting scientific research, and advocating for responsible policy, the association is poised to shape the future of psychedelic-assisted therapies in the UK.
As the demand for mental health treatments continues to grow, PsyIndUK’s work will be crucial in ensuring that psychedelics can be safely and effectively integrated into the UK’s healthcare system. With a focus on innovation, regulation, and collaboration, PsyIndUK is leading the charge toward a new era of psychedelic medicine.