First-in-Man trial for Lobe’s proprietary stabilized psilocin analogue
All subjects dosed with no significant adverse events to date
Lobe Sciences Ltd. (OTCQB: LOBEF) (CSE: LOBE) ("Lobe" or the "Company"), a biopharmaceutical company focused on developing transformative medicines to treat rare diseases today announced the initiation of a Phase 1, pharmacokinetic clinical study of L-130, a proprietary stabilized psilocin analogue drug candidate in healthy volunteers. The first-in-man, open-label study, conducted in Jordan under the authority of the Jordan Food and Drug Administration, will help determine the dose range of L-130 for a planned Phase 2 trial targeting the treatment of chronic cluster headaches (CCH), the most predominant headache disorder within the group of trigeminal autonomic cephalgias (TACs).
“Following the development of our proprietary molecular portfolio targeting the serotonin receptor, we are excited to begin the first of many planned clinical studies to investigate the potential of these psilocin based drug candidates to treat rare diseases and disorders,” stated Philip Young, Chairman and CEO of Lobe Sciences. “Patients who suffer from CCH have no clear pharmaceutical intervention and often resort to off-label treatments and polypharmacy in an attempt to find relief from this debilitating disorder. We believe L-130, with its potent activity on the serotonin receptor may offer a unique solution to CCH patients” added Mr. Young.
The Phase 1 study, conducted in compliance with the GCP and GLP regulatory requirements of the Declaration of Helsinki and the US FDA Guidelines for Bioavailability & Bioequivalence Studies, is 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 will be evaluated for impacts on cognition and anxiolytic effects on day 1, 7 and 28. To date, all subjects have been dosed with no significant adverse events. Full completion of the study is expected in Q3 2023 and results will be used to determine L-130 dose levels for a planned Phase 2a study in chronic cluster headaches.
About Chronic Cluster Headaches
Often said to be the most painful of all headaches, cluster headaches are a primary headache disorder and the most common of the group of headache disorders called trigeminal autonomic cephalalgias. The term cluster headache comes from the fact that these attacks occur in groups, or “clusters.” During a cluster cycle, brief, excruciatingly severe headache attacks recur between 1-8 times per day. Cluster cycles can last for weeks or months and are usually separated by remission periods, or periods of headache freedom, which usually last months or years. People who experience chronic cluster headache have no remission periods, or the remissions last less than a month at a time.
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.
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