Lobe Sciences Ltd. 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). 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 Third Quarter 2023 and results will be used to determine L-130 dose levels for a planned Phase 2a study in 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 headaches comes from the fact that these attacks occur in groups, or "clusters." During a cluster cycle, brief, exceptionally 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.