This Biotech Is Entering The Clinical Stage With A Psilocin Analog Targeting Cluster Headaches

Lobe Sciences Ltd. LOBEF, a biopharmaceutical company focused on non-hallucinatory doses of stabilized psychedelic-based compounds to treat rare diseases, has commenced its Phase 1 clinical study on proprietary psilocin analog L-130. 

Conducted in Jordan under the country’s Food and Drug Administration authority, the first-in-human open-label study will help determine the dose range of novel L-130, tested in 10 healthy volunteers, toward a planned Phase 2 trial targeting the treatment of Chronic Cluster Headaches (CCH.)

Often said to be the most painful type of head pain, cluster headaches are a primary headache disorder and the most common among the trigeminal autonomic cephalalgias group. 

Its name derives from the fact that these attacks occur in groups or “clusters” cyclically, during which brief and painfully severe headache attacks recur between 1-8 times per day. 

While cluster cycles can last for weeks or months and are usually separated by remission periods of months or even years, chronic cluster headaches have either no remission periods or remissions that last less than a month.

The Phase 1 study conducted in compliance with the Declaration of Helsinski’s regulatory requirements as well as FDA guidelines for bioavailability and bioequivalence studies, will evaluate impacts on cognition and anxiolytic effects on days 1, 7 and 28 after the single-dose administration of L-130. 

As of June 27, all subjects have been dosed with no significant adverse events. Full completion of the study is expected in this year’s third quarter and, as mentioned, results will be used to determine L-130 dose levels for an upcoming Phase 2a study in CCH.

Lobe CEO Philip Young said that patients who suffer from this type of disorder “have no clear pharmaceutical intervention” and “often resort to off-label treatments and polypharmacy” in their search for relief, in view of which the company believes L-130’s “potent activity” on the serotonin receptor can potentially offer “a unique solution” to them.

Photo: Benzinga edit with photo by Olia Danilevich on Pexels.