UK psychedelics clinical research organization Clerkenwell Health raised $2.047.710 (£2.1 million) in seed funding, bringing the total to date up to $2.437.750 (£2.5 million), all of which will be used to get the London-based startup fully operational.
Investors of the seed funding round include Lionheart Ventures, Convergence Partners and Exceptional Ventures. The latter was co-founded by Paolo Pio, former MD of Europe at Joyance Partners and Matt Cooper, who also co-founded Capital One Bank, Tandem Bank and was chairman of Octopus Capital Group.
Clerkenwell’s CEO Tom McDonald believes the UK “is extremely well-placed to become the leader in psychedelics research and trials thanks to its globally competitive framework for clinical trials,” which is why the company decided to launch its operations in London.
Paolo Pio added that while psychedelics show great promise in treating mental disorders, the field is “complex and highly regulated,” and that Clerkenwell's founders’ years of experience in the area makes them “the best positioned in the UK and Europe.”
Clerkenwell supports its clients with the design and delivery of drug development and psychedelic-assisted therapy trials, facilitating their research at scale through commercial centers.
Pursuant to the Medicines and Healthcare products Regulatory Agency (MHRA)’s approval, Canadian psychedelics biotech company Psyence PSYGF is set to commence its Phase 2 clinical trial at Clerkenwell’s London site on the efficacy and safety of psilocybin-assisted psychotherapy versus single psychotherapy for the treatment of adjustment disorder due to an incurable cancer diagnosis.
Clerkenwell is also collaborating with Mindset Pharma MSSTF to advance a Phase 1 clinical study evaluating the company’s second-generation psilocybin compound MSP-1014 for the treatment of major depressive disorder (MDD.)
Furthermore, MDMA manufacturer PharmAla Biotech has announced a new agreement with Clerkenwell for regulatory proceedings in the FDA and UK’s MHRA applications for its leading Novel Chemical Entity (NCE), proprietary MDMA analog ALA-002, designed to provide the same efficacy as MDMA with an improved safety profile and fewer adverse effects.
Clerkenwell’s co-founder and CSO Dr. Henry Fisher said, "PharmAla has a unique and exciting strategy, which could present real improvements to clinical development and application of empathogens,” while the engagement with both the MHRA and the FDA represents an important milestone for Clerkenwell in broadening its clinical research footprint.
Besides providing regulatory support for that particular compound in both countries, the agreement includes the potential to drive other, currently under-development molecules through the pharmaceutical regulatory approvals pathway.
PharmAla's vice president of research Dr. Harpreet Kaur said Clerkenwell represents an “excellent partner” to advance the company’s regulatory efforts, holding “excellent experience” with regulatory affairs in two different key jurisdictions as well as being capable of executing clinical research at their UK facility.
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