Lobe Sciences Ltd (CSE:LOBE, OTCQB:LOBED) said it has completed the synthesis of bulk L-130, a proprietary form of psilocin that has the potential to treat severe forms of anxiety.
Lobe CEO Philip J Young said this marks an important step in the validation of the Vancouver-based company’s approach to developing novel psilocin analogues, adding the L-130 was manufactured in compliance with US current good manufacturing practices (cGMPs).
“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 in a statement.
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Phase 1 clinical trials have been contracted with two contract research organizations that will conduct pharmacokinetics, single ascending dose and multiple ascending dose trials. Lobe said it plans to announce the first of this series of human studies soon.
Dr Fred Sancilio, CEO of Clearway Global and head of product development, said Lobe Sciences is using a team of global experts and has moved to the forefront in the development of therapeutics based on psychedelics.
“Our team is following a traditional drug development approach, and has solved many problems that have hindered others trying to develop similar therapeutics," Sancilio said.
Lobe also noted that Young was appointed as executive chair of its board of directors on October 10.
Contact the author at susie@proactiveinvestors.com