London, UK: Small Pharma, a biotechnology company listed on the TSXV: DMT and the OTCQB: DMTTF, and a portfolio company of o2h Ventures, announces positive results from its Phase IIa clinical trial of SPL026 with supportive therapy for the treatment of Major Depressive Disorder (MDD).
Small Pharma is committed to developing short-duration psychedelic-assisted therapies for mental health conditions. The recent announcement of positive results from its Phase IIa clinical trial of SPL026 is a significant step forward in achieving this goal.
This was the first placebo-controlled trial of its sort, and the findings revealed that two weeks after taking SPL026 in conjunction with supportive therapy, patients saw a statistically significant decrease in depression symptoms.
The study was structured in two phases with one or two doses of SPL026 throughout the course of a 14-week trial period. 34 individuals with moderate to severe MDD participated in the trial, and after receiving a short infusion of 21.5 mg of SPL026, they experienced psychedelic effects for 20 to 30 minutes. Including the supportive therapy before and after the infusion, the total treatment session was less than 2.5 hours. The treatment’s efficacy was subsequently evaluated, and it was found that 57% of patients who received a single administration of SPL026 were in remission at 3 months. Going forward, Small Pharma seeks to replicate the result of this study in a larger number of patients in later-stage clinical trials.
o2h Ventures has supported Small Pharma’s mission since 2019 by investing from their human health EIS fund. The company also made a follow-on investment in 2020 to further support Small Pharma’s efforts to develop new and transformative treatments for patients with mental health conditions.
George Tziras, CEO of Small Pharma, said:
MDD affects the lives of hundreds of millions of people worldwide. The scale of the unmet need indicates the importance of investigating alternative new treatments. Our goal is to develop proprietary, scalable and reimbursable short-duration psychedelics with supportive therapy to address this need. I am delighted with our top-line results, which demonstrate proof-of-concept for SPL026 and provide encouraging support for our broader portfolio. I want to thank each patient who took part in this trial, as well as their families, the trial investigators, the employees of the trial sites and everyone who has supported the successful completion of this study.
Sunil Shah, CEO of o2h Ventures, said:
This is a ‘big’ result, and an exciting one for Small Pharma. Depression affects hundreds of millions of people around the world. The use of psychedelics as a medicine is still in its infancy, billions are being invested globally to investigate their effects. For Small Pharma, a London based biotechnology company, to be the first with placebo-controlled clinical data on a short-duration psychedelic drug for Major Depressive Disorder, is a great achievement. A big congratulations to the team at Small Pharma.
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-duration 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 clinical programs of SPL026 and SPL028 with supportive therapy for the treatment of mental health conditions and was granted an Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”) for intravenous SPL026 with supportive therapy for MDD. In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.
About o2h Ventures
The o2h Ventures ‘Human Health’ SEIS and EIS funds make tax-efficient investments in Pre-Seed and Seed stage companies that address human disease: we fund the development of novel therapeutic treatments; we help build new services and tools offerings throughout the biotech ecosystem, and we spur the creation of software & artificial intelligence that will change healthcare.
The o2h team are leaders in the biotech community and have been actively involved as investors, holding various board/industry positions as well as being engaged in grassroots scientific activity for over 20 years. o2h Ventures operates from their proprietary 2.7 acre Mill SciTech Park where they are developing a unique model for incubating small life science companies.