Lobe Sciences Ltd (CSE:LOBE, OTCQB:LOBED) announced that its exclusive commercial manufacturing partner has received an initial 2023 quota for the company’s 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,” CEO Philip Young said in a statement. “We are now in position to initiate two clinical studies within the next several months.”
The first will be a Phase 1 study of L-130 to evaluate its safety and pharmacokinetic profile in healthy volunteers, and the second will evaluate the safety of L-130 in patients with chronic cluster headaches (CCH), Young said.
Lobe’s team was also able to take advantage of a delay in initiating the Phase 1 safety study, which allowed it to draft the necessary documentation to support the conduct of both studies and have an open dialogue with the Food and Drug Association (FDA) leading to the filing of an Investigational New Drug Application (IND) and preparing for a Phase 2 clinical trial in Australia.
Lobe also noted that the quota can be increased as its L-130 program advances.
Lobe is a biopharmaceutical company focused on developing patient-friendly, practical psychedelic medicines. The company, through collaborations with industry-leading partners, is engaged in drug research and development using sub-hallucinatory doses of psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.
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