Small Pharma Inc. confirmed that the first subject has been dosed in a Phase I 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 I 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.