Small Pharma Inc (TSX-V:DMT) revealed it has completed phase one and started phase two of the clinical trial of its psychedelic-assisted therapy for major depressive disorder (MDD).
The company’s DMT-based lead candidate, SPL026, is being tested in combination with psychotherapy.
In what was the world’s first regulated clinical trial for a MDD therapy using N,N-dimethyltryptamine, the chemical name, the intravenous drug was found to be very well tolerated in individuals with no previous experience of psychedelics, the company said.
The placebo-controlled Phase I study saw the drug administered in combination with supportive psychotherapy to 32 healthy psychedelic-naïve volunteers, with no serious adverse events reported and a “robust” dataset on the pharmacokinetics of SPL026.
“This combined data has enabled Small Pharma to select a dose of SPL026, which elicits a breakthrough psychedelic experience and is safe and well-tolerated, to take into patients in Phase IIa,” the company said.
A blinded, randomised, placebo-controlled, proof-of-concept Phase IIa study of SPL026 in combination with psychotherapy in 42 patients with MDD has been initiated at two UK clinical trial sites to assess the efficacy of one versus two doses.
Chief executive Peter Rands said: “The successful completion of Phase I means we can now truly assess SPL026 as a new potential treatment option for patients with MDD.
“There has been little innovation for patients suffering from MDD in the last few decades and SPL026 has the potential to change the mental health treatment landscape and provide a much-needed alternative therapy for patients.”
Dr Carol Routledge, chief medical and scientific officer, added: “We have achieved a significant milestone in the development of SPL026. With a strong safety and tolerability profile, now demonstrated, we can move ahead with the first regulated clinical trial of DMT-assisted therapy in patients. These results lay the foundation for Small Pharma’s DMT-assisted therapy as a potential new paradigm in the treatment of MDD.”