Some psychedelic medicine developers in the United States and Canada have entered into an agreement with Clerkenwell Health in order to carry out trials on their drugs for various mental health indications in the United Kingdom. Clerkenwell Health is a clinical research organization that conducts trials for therapies for a range of mental health illnesses in London.
The drug developers hope to treat mental health conditions such as major depressive disorder, social anxiety, nicotine addiction and autism spectrum disorder as well as adjustment disorder for patients with diagnoses of terminal illnesses, including cancer.
Data from trials conducted in the United Kingdom are globally accepted. This is why many companies carry out phase I and phase II clinical trials there before seeking out larger markets.
The regulatory pathway and fast-track drug approval process in the United Kingdom allows companies to speed up their applications. Since the combined regulatory review process was implemented a few years ago, approval periods have also gotten shorter with ethics applications for fast-tracking that allow approvals in 60 days also being debuted in August this year.
The developers in question include Psyence, Mydecine, PharmAla Biotech and Mindset Pharma; these companies all hope to benefit from the UK’s fast-paced drug regulatory process.
Psyence is a biotechnology company that recently received approval from the Medicines and Healthcare Products Regulatory Agency to conduct trials on its psilocybin-assisted therapy to support patients with terminal cancer through end-of-life care. The company, which is based in Toronto, has a growing facility for hallucinogenic mushrooms in South Africa. Psycence exports these mushrooms to Canada and Portugal for research purposes.
Mydecine is focused on the development of a psilocybin-derived compound for the treatment of tobacco addiction. The company, which is based in Colorado, provided this drug to Johns Hopkins University after it was awarded a grant from the NIH, a federal health agency, for its study on smoking cessation in the United States.
Mindset Pharma is focused on the development of various products, including a compound similar to psilocybin for the treatment of major depressive disorder. Clerkenwell plans to assist Mindset with scientific advice and regulatory submission. Mindset Pharma CEO, James Lanthier, stated that the company was excited to progress its research into how second-generation psychedelic drugs could be utilized in the treatment of psychiatric and neurological disorders.
PharmAla has developed an MDMA-derived drug for the treatment of autism spectrum disorder. The company, which is the only producer of pharmaceutical-grade MDMA within North America, is based in Toronto.
Clerkenwell plans to support PharmaAla via the process of approving its trial by both U.S. and British regulators — the U.S. Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), respectively.
With enterprises such as Mind Medicine Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ) making progress in studies within the United States, success for the companies conducting trials in the UK would bring more psychedelic-based options to patients in need not just in North America but around the world.
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