Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) announced that it has completed enrollment in the Phase IIa clinical trial of its intravenous (IV) formulation of N, N-dimethyltryptamine (DMT) candidate, SPL026, with psychotherapy for the treatment of Major Depressive Disorder (MDD). This formulation recently received patent protection in the United States under patent no. 11,406,629 for injectable formulations of DMT based compounds.
The Phase IIa trial is a blinded, randomized, placebo-controlled, proof-of-concept study of IV SPL026 in combination with psychotherapy, evaluating the efficacy of a single active dose versus placebo at two weeks, and generating a safety and tolerability dataset of SPL026 in patients with MDD. In addition, all participants are rolled into a second phase of the study where they receive a dose of SPL026 with psychotherapy. Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure any changes in the patients’ depression symptoms.
Enrollment into the study and the required dosing for the primary endpoint is now complete. The final dosing session for the second phase of the study is expected to be completed within the next two weeks. All patients are subsequently followed-up for 12 weeks. Topline data is anticipated shortly thereafter.
Dr. Carol Routledge, Chief Medical and Scientific Officer commented:
“The enrollment completion of our Phase IIa trial is an exciting milestone in the development of SPL026. Following encouraging results from our Phase I trial on the safety and tolerability profile of SPL026, the main focus for Phase IIa is exploring treatment efficacy in MDD patients. The key question we are seeking to answer from this trial is whether SPL026 in combination with psychotherapy offers rapid antidepressant effects. The trial design allows us to further explore the potential durability of these effects, which will be informative to our understanding of the clinical potential of this treatment.”
George Tziras, CEO of Small Pharma, commented as well:
“We are delighted to hit this critical milestone in our clinical development program. I would like to thank the team and our partners, including Imperial College London, for their dedication and effort in executing a robust placebo-controlled and blinded DMT-assisted psychotherapy patient study, as well as their commitment to the care of patients throughout this trial. With the last patient now enrolled, we eagerly await analysis of the study results, which will help to inform our plans to move forward into a larger international multi-site Phase IIb trial, and bring us one step closer to delivering potential novel therapies to those suffering with depression.”
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