The article Small Pharma Completes Enrollment in Phase IIa DMT Trial was originally published on Microdose.

Small Pharma has started the week with some positive news. The DMT-focused firm has completed enrollment of their Phase 2a trial for the treatment of Major Depressive Disorder, a major step forward in advancing their top clinical trial.

It’s been a tough week for the markets. Psychedelic stocks are following wider markets in a price pullback, with most of the sector down several percent. Yet Small Pharma has managed to remain stable this week, perhaps due to this news.

Roth Capital has supported this theory, releasing an update to their previous Small Pharma coverage.

“We are reiterating our Buy rating and C$5/share 12-month price target on Small Pharma, following the announcement the completion of enrollment of the SPL026 Phase 2a trial in major depressive disorder (MDD) patients.

The company projects that the final dosing in the second phase will be completed within the next two weeks. Following a further 12-week observation, the two-week (primary endpoint) and 12-week results could be announced in late 2022 / early 2023. This trial represents the first ever randomized, controlled trial with a short-acting psychedelic medicine.”

See below for the full press release and a look at the report.

Small Pharma Completes Enrollment in Phase IIa DMT-Assisted Psychotherapy Clinical Trial in Patients With Major Depressive Disorder

Dosing for primary endpoint now complete

September 19, 2022 07:30 ET | Source: Small Pharma Inc.

LONDON, Sept. 19, 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 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. 11,406,619 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 of Small Pharma, said: “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, Chief Executive Officer, added: “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.”

About Small Pharma

Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into DMT assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside the development of a pipeline of proprietary preclinical assets.

About DMT

DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.

For further information contact:

Small Pharma Inc.

George Tziras, Chief Executive Officer

Email: ir@smallpharma.co.uk

Tel: +1 (646) 751-4363

Investor Relations Contacts:

Eric Ribner

LifeSci Advisors

Email: eric@lifesciadvisors.com

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