Canadian biotech company Lobe Sciences Ltd. (OTCQB:LOBEF) has completed the synthesis of bulk L-130, the company’s proprietary form of psilocin, as well as supplies for its upcoming clinical trials that will assess pharmacokinetics, single-ascending dose and multiple-ascending dose.
Psilocin is a substituted tryptamine -or serotonin analog- alkaloid and a serotonergic hallucinogenic psychedelic substance, present in many psychedelic mushrooms together with its phosphorylated match psilocybin.
Production standards of L-130 followed US Good Manufacturing Practices (GMP). Lobe’s newly appointed board chairman and CEO Philip J. Young said that the news is an “important step and validation” of the company’s approach to developing novel psilocin analogs to treat severe forms of anxiety, including a pediatric orphan indication.
“Our manufacturing partner has produced sufficient quantities of L-130 to dose subjects and patients in our first two Phase 1 programs. Ongoing stability and quality programs are in place to allow the use of all of the data generated in these studies to support our Investigational New Drug Application (IND) planned for early next year,” Young said.
Clearway Global LLC, CEO Dr. Fred Sancilio added: “Our team is following a traditional drug development approach, and has solved many problems that have hindered others trying to develop similar therapeutics.”
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