Lobe Sciences Ltd. provided an update from the Company's lead clinical program, L-130, a proprietary stabilized psilocin conjjugate drug candidate. The Phase 1 study (NCT06035900) was an open label clinical trial in 10 normal and healthy individuals designed to determine the safety and pharmacokinetic parameters of L-130 after a single oral dose. All subjects were evaluated for impacts on cognition and anxiolytic effects on day 1, 7 and 28.

All subjects were dosed with no significant adverse events. The study confirmed the improved pharmacokinetics of L-130 delivered as a shelf-stable, capsule over its active prodrug, psilocybin. The mean maximum plasma concentration (Cmax) for L-130 was significantly higher than expected, demonstrating superior bioavailability compared to published literature of psilocybin.

Additionally, time to achieve the maximum plasma concentration (Tmax) was lower for L-130 due to elimination of first-pass metabolism and immediate absorption in the gut. Full results are expected to be published in peer reviewed journals in the first half of 2024. Collectively, the superior pharmacokinetics of L- 130 offers significant therapeutic advantages over other psilocybin formulations as psilocybin itself is not biologically active in humans and must be converted into psilocin via dephosphorylation in the gut.

By eliminating this first pass metabolism, industry experts believe the direct administration of psilocin may offer therapeutic benefits such as faster onset time, improved dosing consistency, increased bioavailability and importantly, the potential for reduced side effects.