Lobe Sciences Provides Update on L-130 Clinical Program

Lobe Sciences Ltd. (OTCQB: LOBEF) (CSE: LOBE) ("Lobe" or the "Company"), a biopharmaceutical company focused on developing transformative medicines to treat rare diseases today provided an update from the Company’s lead clinical program, L-130, a proprietary stabilized psilocin conjugate 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 inactive prodrug, psilocybin. The mean maximum plasma concentration (C_max) 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 (T_max) 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.

“L-130 was designed based on the needs for a shelf stable oral molecule that can cleanly and consistently deliver psilocin directly, therefore eliminating the inconsistencies we see with the variability of psilocybin due to its need for first-pass metabolism,” stated Philip Young, Chairman and CEO of Lobe Sciences.

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.

“These initial Phase 1 results with L-130 support the industry’s hypothesis regarding the improved characteristics from a pharmacological standpoint of a stabilized psilocin vs that of psilocybin. We look forward to completing the remaining planned Phase 1 trials to further elucidate the dosing regimen and initiate our Phase 2 study in chronic cluster headache in 2024,” Mr. Young concluded.