Lobe Sciences Ltd (CSE:LOBE, OTCQB:LOBED) said it has commenced a Phase 1 clinical study to evaluate L-130, their proprietary stabilized psilocin analogue drug candidate.
The trial aims to determine the appropriate dosage range for a planned Phase 2 trial focused on treating chronic cluster headaches (CCH), the most prevalent headache disorder within the trigeminal autonomic cephalalgias (TACs) group.
In a statement, Philip Young, chairman and CEO of Lobe Sciences, expressed enthusiasm for this milestone, commenting: "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. We believe L-130, with its potent activity on the serotonin receptor, may offer a unique solution to CCH patients."
Conducted in compliance with the regulatory requirements of the Declaration of Helsinki and the US Food and Drug Administration (FDA) Guidelines for Bioavailability & Bioequivalence Studies, the Phase 1 trial is an open-label study involving 10 healthy volunteers. Its primary objective is to assess the safety and pharmacokinetic parameters of L-130 after a single oral dose.
The participants will be evaluated for impacts on cognition and anxiolytic effects on days 1, 7, and 28. Notably, all subjects have received doses thus far without any significant adverse events.
The study is expected to conclude in the third quarter of 2023. The findings will determine the appropriate dose levels of L-130 for the subsequent Phase 2a study, which will focus on treating chronic cluster headaches.
Cluster headaches, often described as the most agonizing form of headaches, are a primary headache disorder within the trigeminal autonomic cephalalgias. These attacks occur in clusters, with excruciatingly severe headache episodes happening multiple times per day. Cluster cycles can persist for weeks or months and are usually followed by periods of remission lasting months or even years. However, individuals with chronic cluster headaches experience little to no remission periods or only experience short remissions lasting less than a month.
Lobe Sciences is dedicated to developing transformative medicines for rare diseases. In collaboration with industry-leading partners, the company is also engaged in drug research and development utilizing non-hallucinatory doses of stabilized psilocin-based compounds to address unmet medical needs in orphan neurological therapeutic applications.
Contact the author at jon.hopkins@proactiveinvestors.com