The first patient has received a dose of psilocybin in the world’s first trial investigating psilocybin as a treatment for a rare and debilitating headache disorder – SUNHA.
Initiated by Beckley Psytech, a private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, the trial aims to explore the potential therapeutic benefits of low-dose psilocybin for treating Short-lasting Unilateral Neuralgiform Headache Attacks (SUNHA).
The disorder is estimated to affect 40,000 patients in the US and Europe, and is typically diagnosed between the ages of 35 and 65. The condition is characterised by short-lasting, painful headaches that can occur over 100 times a day and there is currently no approved treatment for the condition.
World’s first SUNHA trial
The phase 1b clinical trial, which has been approved by the UK Medicine and Healthcare Products Regulatory Agency (MHRA), is being conducted as part of Beckley Psytech’s ongoing collaboration with the Psychedelic Trials Group, led by Dr James Rucker at King’s College London; Dr Manjit Matharu, Consultant Neurologist and Clinical Lead of the Headache Group at the National Hospital for Neurology and Neurosurgery; and Dr Giorgio Lambru, Consultant Neurologist at Guy’s & St Thomas’ NHS Foundation Trust.
CEO of Beckley Psytech, Cosmo Feilding Mellen, commented: “We are very excited to initiate this world-first clinical trial with Dr Matharu and Dr Lambru. This represents a significant milestone for Beckley Psytech and the patients for whom this product has the potential to benefit.
“SUNHA is a severely debilitating disease which affects thousands of patients, and for which there is no currently approved treatment. The potential medical advantages of psychedelic agents, such as psilocybin, could be transformational to the quality of life for those affected by this disease.
“Following on from our recent highly successful $80m funding round and MHRA approval for the upcoming 5-MeO-DMT phase 1 clinical trial, we are delighted to achieve this additional milestone.”
The study is a multi-dose, dose-escalation trial in patients suffering from five or more attacks over the last two weeks, to evaluate proof-of-concept efficacy by analysing the impact on frequency, duration and severity of headaches.
Enrolling up to 12 patients, the trial will assess the proof-of-concept efficacy of psilocybin and determine the maximum tolerated dose or recommended dose for further development. On day one, patients will receive dose one, on day six dose two, on day 11 dose three, with a follow-up visit on day 25.
“I have been involved with research into SUNHA for 22 years and have seen personally the devastating effect this condition can have on so many patients,” said Dr Manjit Matharu, Consultant Neurologist and Clinical Lead of the Headache Group at the National Hospital for Neurology and Neurosurgery.
“I am delighted that Beckley Psytech is developing a truly novel approach which could lead to a safe and effective product for these patients with such a high unmet medical need. I look forward to investigating its safety and efficacy in this ascending dose clinical trial.”
The outcome of the phase 1b study, with proof-of-concept efficacy data, is expected in early 2022.
Psychedelic therapy programmes launch to address heartbreak, burnout and more
Mindbloom has launched its new Mastermind Series of psychedelic programmes for overcoming heartbreak, burnout and other unique mental health challenges.
Led by and developed with leading experts in the field, each programme combines specialised teachings with ketamine therapy.
All programmes will include six ketamine therapy sessions focusing on a specific mental health issue, expert-led audio, video, and written content for preparation, treatment, and integration, practical tools such as meditation, one-on-one coaching and group integration sessions.
The first programme in the Series is ‘Recovering from Rejection and Failure’, led by Dr Guy Winch who is a leading authority on emotional health, and a best-selling author and TED speaker whose talks have received over 30 million views.
Winch’s programme focuses on healing and preventing emotional injuries that people suffer in their personal, professional and romantic lives.
Mindbloom CEO and Founder Dylan Beynon stated: “More than 100 studies and 20 plus years of clinical use show that ketamine therapy may be the most transformational mental health treatment available today.
“In the face of epidemics of mental illness, addiction, and loneliness, we’re thrilled to offer our clients access to top experts across a range of issues – and to pair their expertise with our best-in-class ketamine therapy honed over hundreds of thousands of treatment sessions.”
“Emotional wounds like rejection and failure can be even more devastating than physical wounds, yet we don’t give them the same time and attention,” added Dr Winch.
“I’m thrilled to combine my techniques for emotional first aid with ketamine therapy, which has been shown to increase neuroplasticity and help build emotional resilience.”
“Americans are struggling with heartbreak, burnout, and other challenges every day, and they’re looking for new tools to address them,” said Mindbloom’s Medical Director Dr Leonardo Vando.
“I’m grateful to these experts for providing Mindbloom’s clients with the unique practices and insights they’ve cultivated during their distinguished careers, to help them overcome the biggest obstacles in their lives.”
Psilocybin analogue shows positive results in Phase 2 depression study
Cybin has announced positive Phase 2 topline safety and efficacy data for its proprietary deuterated psilocybin analogue – CYB003 – for the treatment of major depressive disorder (MDD).
Results from Cybin’s study have shown that 79% of patients were in remission from depression at six weeks after receiving two doses of CYB003.
CYB003 demonstrated a large improvement in symptoms after one dose and a total of 79% of patients were responsive to the treatment. The compound also demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to moderate and self–limiting.
Additionally, Cybin has stated that the magnitude of improvement was superior compared to approved antidepressants and recently reported data with other psychedelics, stating that the effects translate into an unprecedented effect size.
The company has said that the results compare favorably to pooled data from 232 industry studies of current standard-of-care antidepressants, SSRIs, submitted to the FDA.
The announcement follows Phase 2 interim results in early November 2023, which demonstrated that CYB003 saw a “rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo”.
Cybin CEO, Doug Drysdale, stated: “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.
“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month.”
Drysdale emphasised that the strength of the data will support CYB003 into Phase 3 of the study.
Cybin CMO, Amir Inamdar, added: “The significant reduction in depression symptoms observed in our Phase 2 study is highly gratifying.
“At the three-week primary efficacy endpoint, a single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS.
“This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo.
“These effects were evident on day one with the 16mg dose and were also highly statistically significant. When data from 12mg and 16mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12mg).
“With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”
Cybin is planning on submitting topline data to the FDA with an aim to hold a Phase 2 meeting in Q1 of 2024, with further 12-week durability data from Phase 2 CYB003 expected in Q1, and recruitment for the Phase 3 study anticipated to begin by the end of Q1 2024.
Mychedelica launches to revolutionise psychedelic medicine
A new company specialising in psychedelic medicine – mychedelica – is offering a comprehensive suite of services to support the advancement of this transformative field.
With a team of experienced medical writers and research support specialists, mychedelica is committed to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in the psychedelic medicine space.
Psychedelic medicine is rapidly gaining recognition for its potential to treat a wide range of mental health conditions, including depression, anxiety, addiction, and post-traumatic stress disorder (PTSD). However, the field is still in its early stages of development, and there is a critical need for high-quality medical writing and research support services to facilitate its progress.
CEO of mychedelica, Bilal Bham, commented: “We are thrilled to launch mychedelica and contribute to the advancement of psychedelic medicine.
“Our team of experienced professionals is dedicated to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in this groundbreaking field.”
mychedelica provides a comprehensive range of services, including:
Medical writing: Experienced medical writers will craft clinical trial protocols, regulatory submissions, and peer-reviewed publications, ensuring that research findings are communicated clearly and effectively.
Funding research support: Experts in grant writing and fundraising strategies will assist researchers in securing funding for their psychedelic medicine studies.
Regulatory consulting: mychedelica’s team of regulatory experts will navigate the complex regulatory landscape surrounding psychedelic medicine, ensuring that clinical trials and products comply with all applicable laws and regulations.
With its commitment to quality and innovation, mychedelica is poised to play a pivotal role in shaping the future of psychedelic medicine. The company’s services will empower researchers to conduct rigorous clinical trials, clinicians to provide effective treatments, and pharmaceutical companies to develop safe and effective psychedelic medicines.
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