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Press Release: Psyence Biomed Announces Export of Nature-Derived Psilocybin to Australia and Provides Update on Upcoming Phase IIb Trial

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NEW YORK, July 24, 2024 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today announced the export of nature-derived psilocybin to Australia and provided an update on its upcoming Phase IIb clinical trial evaluating nature-derived psilocybin as a potential treatment for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context.

The Company previously announced that it had entered into partnerships with Fluence, a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support the study. Following a recent site visit by Psyence Biomed leadership to partners and trial sites in Australia, the Company is preparing to initiate the study shortly following the recent successful export of drug candidate, PEX010, from its current supplier, Filament Health.

“Over the past several months, we have made substantial progress preparing for our Phase IIb study, and following my recent site visit to Australia, I am pleased to report that all parties, including Psyence and our partners, Fluence and iNGENū, are poised to initiate the study imminently,” said Dr. Clive Ward-Able, Medical Director of Psyence Biomed. “With the successful export of PEX010, we now plan to focus on the efficient enrollment of patients into this important study.”

The randomized, double-blind, placebo-controlled Phase IIb study will evaluate two therapeutic doses of nature-derived psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 84 patients in conjunction with psychotherapy. Psyence aims to execute an efficient yet rigorously designed study that, if successful, would best support advancement into future late-stage studies.

More information on the study can be found at: 12624000449538p.

Filament Health Commercial Licensing Agreement Update

Psyence Biomed’s commercial licensing agreement with Filament Health, which covered supply of PEX010 for pivotal Phase III studies in Adjustment Disorder and also granted Psyence Biomed the worldwide right to commercialize PEX010 (25 mg) within the context of Palliative Care, remained subject to further negotiations between the parties and the completion of a subsequent definitive agreement within a predefined time period.

Following further discussions, both parties have mutually agreed to terminate the commercial licensing agreement. Filament Health will continue to support the supply PEX010 for the upcoming Phase IIb trial, as previously announced. Psyence Biomed is evaluating two exclusive supply and license agreements with duly licensed suppliers operating in the United Kingdom and North America. The Company intends to provide further updates on such agreements as they are executed. However, there can be no guarantees that such agreements will be finalized.

“We have made significant progress identifying alternative suppliers of nature-derived, non-synthetic psilocybin for use in subsequent clinical studies, and we look forward to securing a partner that can support our needs over the long-term,” stated Dr. Neil Maresky, CEO of Psyence Biomed. “Importantly, this change should have minimal impact on our internal development timelines for our Phase IIb program, and we remain committed to introducing a novel therapy for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context as efficiently as possible.”



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UK’s First Psychedelic Trade Association Launched

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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, PsyIndUK brings 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​.

UK’s First Psychedelic Trade Association Launched A Significant Milestone for the Industry
UK’s First Psychedelic Trade Association Launched A Significant Milestone for the Industry

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.



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Can Psychedelics Treat Addiction and Alcoholism?

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Psychedelics, once associated primarily with counterculture and recreational drug use, are now being seriously studied for their therapeutic potential in treating drug addiction and alcoholism. Recent research has shown that substances like psilocybin, LSD, and ayahuasca may have profound benefits for individuals struggling with Alcohol Use Disorder (AUD) and substance use disorders (SUD). These compounds are being reconsidered not only for their ability to induce altered states of consciousness but also for their potential to address addictive behaviors and psychological trauma at the root of addiction.

Psilocybin’s Efficacy in Treating Alcohol Use Disorder

One groundbreaking study, conducted at New York University and Johns Hopkins University, demonstrated the potential of psilocybin in treating Alcohol Use Disorder (AUD). The researchers focused on individuals with severe AUD, administering two doses of psilocybin in conjunction with psychotherapy. The results were notable: participants reported a 50% reduction in heavy drinking days over an eight-month period, with some maintaining abstinence from alcohol even a year later.

The trial followed a double-blind, randomized approach and found that the therapeutic effects of psilocybin were superior to those observed with placebo treatments. Dr. Michael Bogenschutz, a lead researcher in the study, emphasized the importance of the psychedelic experience itself in breaking the cycle of addiction. Psilocybin appears to help patients break through entrenched mental patterns, often revealing deeper emotional connections and realizations that drive more meaningful behavior change​.

How Psychedelics Influence the Brain to Combat Addiction

The mechanism behind the efficacy of psychedelics in treating addiction is thought to involve neuroplasticity, or the brain’s ability to reorganize and form new connections. By interacting with serotonin 2A receptors, particularly in the prefrontal cortex and default mode network, psychedelics can enable profound shifts in perception and cognition. These altered states of consciousness allow individuals to confront underlying psychological issues, such as trauma or negative emotional patterns, which are often at the core of addictive behaviors​.

Many individuals undergoing psychedelic-assisted therapy report experiencing a “reset” of their mental state, facilitating a more open mindset that helps them engage with therapy in a deeper, more effective way. This contrasts with traditional addiction treatments, such as methadone or buprenorphine, which primarily manage withdrawal symptoms but do not address the psychological components of addiction.

LSD and Its Potential in Addiction Treatment

LSD (lysergic acid diethylamide) has also shown promise in treating addiction, particularly alcoholism. Early studies from the 1950s to the 1970s suggested that LSD might help reduce alcohol dependency, but interest in this line of research waned due to regulatory crackdowns on psychedelic research. However, more recent studies have reignited interest in LSD’s therapeutic potential.

A meta-analysis published in the Journal of Psychopharmacology reviewed data from six trials involving over 500 patients. It concluded that a single high dose of LSD, administered in a therapeutic setting, was associated with a significant reduction in alcohol consumption. The study found that LSD’s psychedelic effects could lead to lasting changes in personality traits, such as openness and emotional resilience, which are crucial for overcoming addiction​.

Ayahuasca and Addiction Recovery

Ayahuasca, a traditional Amazonian brew containing DMT (dimethyltryptamine) and MAO inhibitors, has been the focus of recent studies examining its potential to treat addiction. Researchers have found that ayahuasca’s intense psychoactive properties, combined with its ability to facilitate introspection and emotional healing, may help individuals overcome opioid and stimulant addiction. A study published in Frontiers in Pharmacology noted that ayahuasca led to significant improvements in mental health and reductions in addictive behaviors​.

Ayahuasca ceremonies, often conducted in a spiritual context, have been shown to promote healing through vivid and sometimes challenging visions. Participants often report gaining insights into the underlying causes of their addiction, leading to long-lasting psychological benefits.

Challenges in Psychedelic-Assisted Therapy

While the results of these studies are promising, the use of psychedelics in treating addiction is not without challenges. For one, the psychedelic experience itself can be unpredictable, and not all patients experience the profound mystical or emotional breakthroughs associated with positive outcomes. The effectiveness of psychedelic-assisted therapy appears to be linked to the quality of the therapeutic environment and the expertise of the facilitators, meaning that careful preparation and integration are key to success.

Moreover, while psychedelics like psilocybin and LSD do not appear to be physically addictive, their use must still be carefully regulated to prevent potential psychological risks, such as hallucinations, anxiety, or psychotic episodes in vulnerable individuals. Current research emphasizes the need for controlled settings where trained therapists can guide patients through their psychedelic experiences.

Ongoing Research and Future Directions

Given the promising early results, psychedelic research is entering a new phase, with larger clinical trials currently underway. The National Institutes of Health (NIH) recently allocated $2.4 million to explore the use of psychedelics in treating methamphetamine addiction, further solidifying the role of psychedelics in addiction therapy​. Similarly, ongoing studies are looking into psilocybin’s potential to treat opioid addiction and cocaine dependence, conditions that have been notoriously difficult to treat with conventional methods.

As research progresses, it is likely that psilocybin, LSD, and other psychedelics will become more widely recognized as effective tools for addiction treatment. While more research is needed to fine-tune these therapies and better understand their long-term effects, early indications are that psychedelics could revolutionize addiction and alcoholism treatments in the coming decades.

Conclusion

Psychedelics like psilocybin, LSD, and ayahuasca are emerging as potential breakthrough therapies for treating drug addiction and alcoholism. By promoting neuroplasticity and addressing the psychological roots of addiction, these substances offer an alternative to traditional addiction treatments, which often focus on managing symptoms rather than curing the disease. With ongoing research and increasing clinical trials, psychedelic-assisted therapy may become an essential tool in the fight against substance use disorders, offering hope to millions of people who struggle with addiction, such as alcoholism.

Sources

Johns Hopkins Medicine: Psychedelics in Addiction Treatment
Progress in Neuro-Psychopharmacology and Biological Psychiatry
National Institutes of Health (NIH) Research on Psychedelics
Frontiers in Pharmacology: Ayahuasca for Addiction Recovery
JAMA Otolaryngology – Head & Neck Surgery



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Prince Harry’s U.S. Visa Drug Case Quietly Closed, Details Sealed

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The U.S. legal case surrounding Prince Harry’s visa application and his admitted drug use has quietly come to a close, with a federal judge issuing a sealed ruling. The case was initiated after Prince Harry’s public revelations in his memoir, Spare, where he openly discussed his past use of drugs such as cocaine and psychedelics. These admissions raised questions about whether he received special treatment from U.S. immigration authorities, as such disclosures could, under normal circumstances, complicate or bar entry to the U.S. under existing immigration laws.

The legal action was spearheaded by the Heritage Foundation, a conservative think tank, which sought transparency regarding whether the Department of Homeland Security (DHS) followed standard procedure when granting Harry his visa. They filed a lawsuit under the Freedom of Information Act (FOIA) to compel DHS to release Prince Harry’s visa records. The group’s argument was rooted in the public’s right to know if a high-profile figure like Harry was given preferential treatment in his immigration process.

The Sealed Ruling and Lack of Public Disclosure

The federal judge, Carl Nichols, closed the case quietly and opted to seal the ruling, meaning the public will not have access to the details of the decision. This has left many questions unanswered, particularly around whether Prince Harry’s admissions of prior drug use were factored into his visa application process. Under U.S. immigration law, prior drug use can be grounds for visa denial, especially if disclosed during the application process. However, because the ruling is sealed, it remains unclear if his application received special consideration.

Legal experts believe that sealing the ruling is not uncommon in cases involving privacy concerns or high-profile individuals. The closure of the case without public disclosure could be an effort to shield the U.S. government and Prince Harry from further scrutiny while allowing room for potential appeals or other legal steps that may be taken in private​.

Background and Public Interest

The legal scrutiny of Prince Harry’s visa application came after his candid admissions in Spare and various interviews where he spoke openly about using drugs, including psychedelics for therapeutic purposes. In his memoir, Harry detailed his use of drugs to cope with the mental and emotional stress following his mother, Princess Diana’s, death. He also admitted to using cocaine recreationally in his youth. His honesty sparked debates over whether someone with his history would ordinarily be permitted to live in the United States, raising concerns about the transparency of U.S. immigration processes when it comes to high-profile individuals.

The Heritage Foundation argued that the public deserved to know if DHS had granted Harry any exemptions or leniencies in light of his admissions. Under normal circumstances, U.S. visa applicants are required to disclose any drug use, which can lead to rejection or additional scrutiny in the application process. Despite these concerns, the judge’s ruling, by being sealed, avoids making any explicit details about Harry’s visa or potential leniencies publicly available.

Legal Precedents and Considerations

Immigration law experts have noted that while drug use is generally a red flag for visa applicants, there are pathways to admission even for those who have admitted to previous drug use. The case, however, has raised broader questions about the fairness and consistency of U.S. immigration enforcement. It is unknown if Harry’s celebrity status played any role in the handling of his visa application, and the sealed ruling leaves room for speculation.

Additionally, under U.S. law, drug use disclosed after entry into the country, such as through a memoir, does not automatically trigger deportation or visa cancellation. The DHS’s refusal to release Harry’s visa records—despite the public interest—further fuels debate over the transparency and fairness of how immigration laws are applied to individuals with high profiles.

Prince Harry’s U.S. Visa Drug Case Quietly Closed, Details Sealed
Prince Harry’s U.S. Visa Drug Case Quietly Closed, Details Sealed

The Heritage Foundation’s Argument

The Heritage Foundation, which pursued the FOIA lawsuit, has expressed disappointment with the closure of the case and the sealed ruling. They maintain that the public deserves to know whether Prince Harry was treated differently than ordinary applicants. The case, however, highlights a tension between the public’s right to know and the privacy rights of individuals, particularly those with a high level of fame and media attention.

Despite the Foundation’s push for transparency, the government’s stance on withholding the records reflects the complexities of balancing public interest with personal privacy, especially under the protections afforded by U.S. immigration law. The sealed ruling may indicate that no significant irregularities were found, but without public access to the decision, speculation remains.

What’s Next?

Although the case has been closed, Prince Harry’s visa status may remain a point of public interest, especially in light of upcoming political dynamics. Notably, former U.S. President Donald Trump hinted that, if re-elected, he might re-examine Prince Harry’s visa status, potentially opening up further political debates about immigration policies for high-profile individuals.

For now, the case’s quiet closure suggests that both the U.S. government and Prince Harry prefer to avoid further public scrutiny, keeping the specifics of his visa application confidential.

Conclusion

Prince Harry’s visa case, which raised questions about his admissions of drug use and how they were handled by U.S. immigration authorities, has been quietly closed with a sealed ruling. While the decision leaves many questions unanswered, it highlights the complex interplay between privacy, public interest, and immigration law. The public may never fully know whether Harry’s visa was granted under special conditions or if his case was handled routinely, but the debate over transparency in immigration decisions involving high-profile individuals will likely persist.



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