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Phase 1 results show significantly increased bioavailability for its stable psilocin compared to psilocybin
L-130 Phase 2 Trial Planned for 2024
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.
Management will be meeting with prospective investors and corporate partners during the 42 nd Annual J.P. Morgan Healthcare Conference in San Francisco on January 8-11. To schedule a meeting please contact ir@lobesciences.com
About lobe sciences ltd.
Lobe Sciences is a biopharmaceutical company focused on developing transformative medicines to treat rare diseases. The Company, through collaborations with industry-leading partners, is additionally engaged in drug research and development using non-hallucinatory doses of stabilized psilocin based compounds to address unmet medical needs in orphan neurological therapeutic applications.
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Forward Looking Statements
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact included in this news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com . As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.
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lobe sciences ltd.
Investor and Media
ir@lobesciences.com
Tel: (949) 505-5623
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