Small Pharma Inc (TSX-V:DMT) (TSXV:DMT) reported "strong progress" in the Phase I/IIa clinical trial of its lead product and said preparations are underway for a Phase IIb trial anticipated to begin next year.
The neuropharmaceutical company focused on psychedelic-assisted therapies posted a trading update on Friday covering an eventful three months to end-May, which included the completion of a reverse takeover transaction that resulted in the company’s share becoming listed on the TSX Venture Exchange (TSX-V), following the successful raising of US$58mln in new funding.
Phase I/IIa clinical trials are being completed for its lead product, SPL026, a therapy for the treatment of depression built around N,N-dimethyltryptamine (DMT), a psychedelic compound found naturally within plants as well as in animals and humans.
A fourth cohort of patients has been treated in the Phase I component of the study, allowing for the acceleration of the Phase IIa proof of concept component of the study.
After a second clinical trial site was secured in the UK for this Phase IIa study, it is expected to start before the end of September, with top-line results now anticipated in the first half of next year.
The company also reported “positive discussions” with the UK Medicines and Healthcare products Regulatory Agency (MHRA) on the design for the Phase IIb trial that is planned to begin in the second half of 2022.
Last month, Small Pharma said it had received ‘granted’ UK patent status for its longer-duration potential DMT treatments for depression, including its SPL028 product.
It anticipates completion of pre-clinical studies of SPL028 by the year end, with start of Phase I/IIa anticipated to start in the first half of 2022.
Chief executive Peter Rands said: “We have made considerable progress leading the first DMT clinical trial under regulatory approval.”
After the US$58mln financing and subsequent listing on the TSXV he added: “The continued support of our investors and a stable financial base is expected to assist us with our objective of rapidly progressing and building out our patent portfolio in the coming year, creating a strong foundation for advancing DMT-based therapies for mental health conditions.”