Mr. Philip Young reports

LOBE SCIENCES INITIATES PHASE 1 CLINICAL TRIAL OF L-130

Lobe Sciences Ltd. has initiated 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 cephalalgias (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 chief executive officer 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 (good clinical practice) and GLP (good laboratory practice) regulatory requirements of the Declaration of Helsinki and the U.S. Food and Drug Administration guidelines for bioavailability and 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 one and eight 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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