Biotech psychedelics company Small Pharma Inc. (OTCQB:DMTTF) has received an Issue Notification from the United States Patent and Trademark Office (USPTO) confirming that its patent application for novel injectable formulations of DMT-based compounds has been approved and will be granted as of August 9, 2022 in the United States.
“We believe that this patent, covering our two most advanced DMT programs, 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," said chief of innovation and IP officer Peter Rands.
In February 2021, the company initiated its clinical program for DMT-assisted therapy, including a Phase I/IIa trial on its lead candidate together with the development of several proprietary preclinical assets.
This new patent constitutes Small Pharma’s ninth issued patent, yet the first U.S. patent grant for its psychedelic portfolio. It includes proprietary formulations of DMT, the active ingredient in SPL026, and of deuterium-substituted DMT, including the active ingredient in SPL028, as well as novel injectable formulations of known psychedelic compounds including 5-methoxy-DMT and psilocybin.
On the obtained approval, Rands stated that diligent assessment of clinical and commercial potential of mental health treatments, which “requires a strong patent approach to protect our formulations,” is key for the company to succeed on its mission.
On his behalf, CEO George Tziras announced, besides being a major milestone in the company’s development strategy, the new U.S. patent “is also timely, as we anticipate dosing completion in our SPL026 Phase IIa trial in patients with Major Depressive Disorder (MDD), and prepare for a Phase I study of SPL028 in healthy volunteers in the second half of this year.”
In Tziras’ view, “the U.S. will be an important market for DMT-assisted therapies as we look to shape the future of mental health treatments.”
A Short Reminder Of What DMT Actually Is
DMT is a naturally-occurring psychedelic tryptamine found in plants as well as in the brain of mammals. Recent scientific evidence is suggesting it offers the potential for rapid-acting and long-lasting antidepressant effects.
DMT is differentiated by its short psychedelic experience (usually less than 30 minutes), which makes short treatment sessions possible and therefore could offer the potential for affordable supervised treatments within patient clinics.
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