psilocin mucate (L-130) / Lobe Sci - LARVOL DELTA

Psilocin-1: Evaluation of Safety, Rate and Extent of Absorption of Psilocin Mucate (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Lobe Sciences Ltd.

New P1 trial

Lobe Sciences Ltd. Announces That The Drug Enforcement Administration Has Issued The Initial 2023 Quota Allowing Export Of L-130 (Yahoo Finance) - "Lobe Sciences Ltd...announced that its exclusive commercial manufacturing partner has received their initial 2023 quota for our novel psilocin drug product (L-130) from the Drug Enforcement Administration (DEA)....'This is the final step of the DEA process which is required for the commercial production of Schedule 1 compounds for export for the conduct of human clinical trials....We are now in position to initiate two clinical studies within the next several months. The first will be our Ph. 1 study of L-130 to evaluate its safety and Pharmacokinetics profile in healthy volunteers. The second study...will evaluate the safety of L-130 in patients with Chronic Cluster Headaches ('CCH').'"

Commercial • New P1 trial • Chronic Cluster Headache • CNS Disorders

Lobe Sciences Ltd. Announces Exclusive Collaboration with Quality Chemical Laboratories LLC (Yahoo Finance) - “Lobe Sciences Ltd…announced that its exclusive discovery and manufacturing partner Quality Chemical Laboratories LLC (‘QCL’) has initiated commercial formulation activities for L-130. QCL, in collaboration with Clearway Global, LLC, will prepare the chemical, manufacturing and control section of the investigational new drug application being filed later this year. Material produced at QCL will also be used in the recently announced Phase I/IIa study to evaluate L-130 as a treatment for chronic cluster headaches, a debilitating orphan disease.”

IND • Licensing / partnership • Chronic Cluster Headache • CNS Disorders