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Small Pharma receives patent grant for DMT injectable formulation

The patent will also protect novel injectable formulations of other known psychedelic compounds.

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UK-based Small Pharma has announced that its DMT patent strategy has been strengthened with a new US patent protection on injectable DMT delivery in its lead programmes SPL026 and SPL028.

Small Pharma has received Issue Notification from the United States Patent and Trademark Office that its patent application will be granted on 9 August, 2022 in the US.

The patent is for novel injectable formulations of N, N-dimethyltryptamine (“DMT”) based compounds, and includes novel injectable formulations of other psychedelic compounds, including 5-MeO-DMT and psilocybin.

Chief Innovation and Intellectual Property Officer of Small Pharma, Peter Rands, said: “Our focus is on developing novel and scalable mental health treatments for patients who are under-served by current medicines. 

“This means diligent assessment of both clinical and commercial potential, and requires a strong patent approach to protect our formulations. We believe that this patent, covering our two most advanced DMT programmes, SPL026 and SPL028, will provide protection of those assets until August 2041. 

“We have focused on protecting our pipeline assets through novel chemistry and, in this case, optimized finished dosage forms.”

The patent represents Small Pharma’s ninth issued patent, and will be the first US patent grant within the company’s psychedelic portfolio, which includes over 70 pending applications, and includes formulations of DMT, the active ingredient in SPL026, and of deuterium-substituted DMT, including the active ingredient in SPL028. 

George Tziras, Chief Executive Officer, added: “This US patent represents a major milestone in our development strategy. It is also timely, as we anticipate dosing completion in our SPL026 Phase IIa trial in patients with Major Depressive Disorder, and prepare for a Phase I study of SPL028 in healthy volunteers in the second half of this year. 

“For Small Pharma’s longer-term vision, the  U.S. will be an important market for DMT-assisted therapies as we look to shape the future of mental health treatments.”

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