The article Small Pharma Completes Phase IIa Trial and Secures New IP was originally published on Microdose.
DMT-development firm Small Pharma has moved its lead candidate drug further through the clinical trial process with the completion of its Phase 2a trial. See the full press release below.
This is the industry most advanced DMT trial and is another milestone in Small Pharma’s understated yet steady march forward.
For more on Small Pharma check out: Small Pharma Expands IP With Another US Patent and Small Pharma Receives Approval for Phase I DMT Clinical Trial
Small Pharma Announces Completion of SPL026 Phase IIa Trial and Secures New Intellectual Property
Last patient last visit complete in SPL026 Phase IIa clinical trial with topline results expected early in Q1
European patent granted for synthetic manufacturing process of key pipeline candidates
LONDON, Dec. 22, 2022 (GLOBE NEWSWIRE) — Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, today announces that the last patient has completed its final visit in the Phase IIa clinical trial of SPL026, intravenous N,N-dimethyltryptamine (“DMT”), with supportive therapy, for the treatment of Major Depressive Disorder (“MDD”).
Dr. Carol Routledge, Chief Medical and Scientific Officer, said: “The last patient visit marks a significant milestone in our clinical program for SPL026. We will now move rapidly into data analysis, and plan to report the key trial results within weeks. This is the first completed placebo-controlled patient study to date exploring a short-acting psychedelic as a potential treatment for MDD, and we eagerly anticipate the results.”
The proof-of-concept Phase IIa clinical trial investigates intravenous SPL026 with supportive therapy, in MDD patients. This two-staged study included a blinded, randomized, placebo-controlled phase, where the primary endpoint was to assess the efficacy of a single dose of SPL026 versus placebo. In addition, all participants were rolled into an open-label phase of the study where they each received an active dose of SPL026 and were subsequently followed-up for 12 weeks. This trial design enables the assessment of secondary endpoints including the efficacy, safety, and tolerability of one versus two doses of SPL026. Efficacy is being assessed using the Montgomery-Asberg Depression Rating scale to measure any potential change in patients’ depression.
European Patent Grant
On December 21, 2022, the Company was granted patent no. 3 873 883 by the European Patent Office. The European patent protects a manufacturing process for the preparation of synthetic DMT, DMT-related compounds and deuterated DMT analogs. The claimed novel manufacturing process produces an efficient, Good Manufacturing Practice (GMP) compatible formula, that is inexpensive to manufacture and scalable for commercial purposes.
The European patent covers the preparation of the Company’s pipeline candidates SPL026 and SPL028. This patent marks the first grant within the Company’s synthetic route patent family, with patent applications pending in multiple additional jurisdictions, including the United States and Canada.
George Tziras, Chief Executive Officer, added: “Innovation is a key pillar of our Company strategy, and we have made great strides this year in protecting the intellectual property portfolio surrounding our innovation. The grant of this latest European patent brings us to 14 granted patents in total, including key grants within each of our core areas of patent protection. We close out 2022 with great momentum, and we look forward to continuing this trajectory into 2023.”
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelic-assisted therapies for the treatment of mental health conditions. The Company’s current focus is on exploring new therapeutic approaches for depression. Small Pharma’s lead candidate, SPL026, is a proprietary synthetic formulation of DMT. The Company is advancing a clinical program of intravenous SPL026 with supportive therapy for the treatment of Major Depressive Disorder, which was granted an Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency (“MHRA”). In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.