First Subject Dosed in Small Pharma’s First-in-Human Phase 1 Clinical Trial

Small Pharma Inc. recently confirmed the first subject has been dosed in a Phase 1 study evaluating SPL028, its deuterated N, N-dimethyltryptamine (DMT) candidate, with supportive therapy in healthy volunteers. This is the first-in-human trial investigating the profile of SPL028, the company’s proprietary molecule with Composition of Matter protection.

Small Pharma’s preclinical studies suggest that SPL028 offers a similar safety and pharmacological profile to its lead candidate SPL026, or DMT, while being differentiated by its pharmacokinetics. The company aims to deliver a treatment with an extended psychedelic experience in comparison to 20-25 minutes with SPL026, but still significantly shorter than the experience of other psychedelics, such as psilocybin and lysergic acid diethylamide (LSD). Through the SPL028 clinical program, Small Pharma is exploring whether an extended duration could offer a treatment tailored for other mental health conditions in addition to depression. Additionally, the pharmacokinetic profile of SPL028 offers the opportunity to explore additional routes of administration, potentially expanding patient convenience.

The Phase 1 study is a randomized, blinded, placebo-controlled, dose-escalating study being conducted at MAC Clinical Research in Manchester, England. It is designed to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of both intravenous (IV) and intramuscular (IM) administration of SPL028.

Dr. Carol Routledge, Chief Medical and Scientific Officer, said “With the SPL028 trial now underway, we look forward to learning more about its pharmacokinetic and pharmacodynamic properties in humans. Comparison of the IM and IV routes of administration in this study aims to create options for patients and physicians, which may help to expand convenience and accessibility. We expect that the results from this Phase 1 study will enable us to make a data-driven decision in selecting the dose and route of administration to take forward into a patient study.”

George Tziras, Chief Executive Officer, added “This is a significant milestone for Small Pharma, with our second key program now in clinical development. The recent announcement on January 25, 2023 of our positive Phase 2a results demonstrates proof-of-concept for SPL026 in treating major depression. These encouraging results also provide support for our portfolio of DMT-based assets, and give us confidence in driving forward both our SPL026 and SPL028 programs.”

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 UK Medicines and Healthcare products Regulatory Agency (MHRA) for IV SPL026 with supportive therapy for Major Depressive Disorder. In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.