PATIENTS DOSED WITH METHYLONE IN LONDON IN NEW CLINICAL TRIAL TO TREAT PTSD
- Methylone, a non-hallucinogenic, rapid-acting neuroplastogen is being evaluated as a treatment for people diagnosed with PTSD
- Resistance against conventional talking therapies and medicines means there is significant demand for new and effective treatments for PTSD
London, 17th October 2023 – Clerkenwell Health, the modern mental health company specialising in matching patients with cutting-edge psychiatry treatments, today announced that it is taking part in Transcend Therapeutics’ Phase 2 study evaluating the safety and efficacy of methylone in patients with severe PTSD.
The clinical trials, which are being conducted at Clerkenwell Health’s purpose-built facility near Harley Street in London, sees patients administered with methylone – a rapid-acting neuroplastogen which has short-acting and mild psychological effects - and could require less clinician time for administration, making it potentially well-suited for integration into the existing medical system.
Dr Henry Fisher, Chief Scientific Officer at Clerkenwell Health, said:
“PTSD has distressing symptoms including flashbacks, nightmares and numbing, and it is estimated that 1 in 10 people in the UK may develop the condition in their lives.
“Meanwhile more than eight million people in England alone are on antidepressants, rising by over a million people in just five years, and only 50% of people receiving psychological therapies move towards recovery. The status quo for mental health treatment just isn’t working, and the NHS is struggling to cope with the pressure.
“By rolling out these clinical trials in the UK we hope to contribute to a growing body of research which supports the development of the next wave of innovative treatments for neuropsychiatric diseases.”
Blake Mandell, Co-Founder and Chief Executive Officer at Transcend Therapeutics, said:
“We know from a published clinical case series and other research that methylone could hold tremendous promise for the treatment of PTSD. We are grateful to Clerkenwell Health for partnering on this trial, which will provide invaluable data on the efficacy and safety of methylone for PTSD. We look forward to reviewing the results of this study, and ultimately bringing new and more effective treatments to the market for the millions of people globally who suffer from PTSD.”
1 in 10 people in the UK are expected to experience PTSD at some point in their lives. In the UK, that’s around 6,665,000 people who are expected to develop PTSD or C-PTSD, or complex post-traumatic stress disorder, yet it is still an incredibly misunderstood, often misdiagnosed and stigmatised condition.
The symptoms of PTSD include:
- Re-experiencing (including recurrent distressing images, thoughts, dreams or perceptions of the event)
- Avoidance and numbing (avoiding thoughts, feelings, activities or conversations associated with the trauma; diminished interest or participation in activities, feelings of detachment or estrangement from others)
- Hyperarousal (including difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hypervigilance and an exaggerated startle response).
Transcend expects initial top-line data from the open-label portion of the study by the end of 2023. Following completion of the open-label portion of the study (Part A), Transcend will launch Part B, a randomized, double-blind, placebo-controlled, evaluation of methylone with up to 64 patients with PTSD.
Experts in finding mental health patients and training the specialised therapists needed to deliver new treatments, Clerkenwell Health’s hybrid research and treatment model provides access to treatments still in R&D through clinical trials or approved treatments through an international network of clinics.
About IMPACT-1 Study
The IMPACT-1 study is a two-part clinical trial to evaluate the safety and efficacy of methylone as a treatment for PTSD. In Part A, participants are treated with once a week for 4 weeks with open-label methylone and followed for an additional 6 weeks. In Part B, participants will be randomly allocated to receive methylone or placebo once a week for 4 weeks and followed for an additional 6 weeks. Eligible participants are 18 to 70 years of age, with a confirmed diagnosis of PTSD, and have tried at least one PTSD treatment unsuccessfully – either psychotherapy or pharmacological treatment – and not currently on any active treatments (https://clinicaltrials.gov/study/NCT05741710).
About Clerkenwell Health
Clerkenwell Health is the modern mental health company specialising in matching patients with cutting-edge psychiatry treatments.
Clerkenwell Health’s vision is to fundamentally change the face of mental healthcare by building the clinical research expertise and care delivery platform needed for a new wave of mental health and neurological treatments – including psychedelic medicines and braincare technologies.
Experts in finding mental health patients and training the specialised therapists needed to deliver new treatments, Clerkenwell Health’s hybrid research and treatment model provides access to treatments still in R&D through clinical trials or approved treatments through an international network of clinics.
Clerkenwell Health is already recruiting for clinical trials 3x faster than its competitors, have a 600+ therapist waiting list, and are backed by leading mental health and technology investors Matt Cooper, Exceptional Ventures, Vine Ventures, Convergence Partners and Lionheart Ventures.
About Transcend Therapeutics
Transcend Therapeutics, founded in 2021, is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The company's mission is to develop new drugs for the millions of people for whom current psychiatric medicines have not worked. Transcend's lead product candidate, methylone, a rapid-acting neuroplastogen, is currently being evaluated in a Phase 2 study in PTSD. Transcend's leadership team has made pivotal contributions to 13 FDA approvals and $7B in M&A and public company value. As a Public Benefit Corporation, Transcend has pledged 10% of its founding shares toward nonprofits focused on scientific research and patient access.
