Lobe Sciences Ltd (CSE:LOBE, OTCQB:LOBED) has announced the development of its initial Phase 1 study plan to demonstrate the safety and appropriate dosing range for its proprietary new chemical entity L-130, a unique synthetic analogue of the psychedelic psilocin, to treat neurologic disorders.
The company also announced that it has acquired a second new chemical entity L-131 which is expected to enter preclinical toxicity trials later this year or early next year to enable Phase 1 trials planned for later in 2023.
Lobe CEO Philip Young said both chemical entities were unique synthetic analogues of psilocin, the active metabolite of natural psilocybin which is a substance extracted from a species of psychedelic mushroom.
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“We have designed a regulatory development strategy to support the registration of these new chemical entities with the US Food and Drug Administration (FDA),” he said.
“Our initial focus for our clinical program is to treat neurologic disorders, such as severe anxiety, and we are in the final stages of selecting a contract research organization to support these studies.”
Lobe said it expects to submit a Pre-Investigational New Drug (IND) meeting request with the FDA in the third quarter. After receiving the FDA’s response to its Pre-IND questions, the company said it would file its IND application with plans to move forward with its initial clinical study later this year or early in 2023.
The company said its initial Phase 1 study would evaluate the safety of L-130 in healthy volunteers in a single ascending dose. This will be followed by a second Phase 1 trial to evaluate the longer-term use of the drug candidate in a multiple ascending dose study.
Once an appropriate dosing level is determined to have no hallucinatory effect, the company said it would conduct a third and final safety study in patients evaluating both the pharmacokinetics and preliminary efficacy at the selected dose.
The trial will also seek to confirm the synergistic effects seen in preclinical studies when combinations of N-acetyl cysteine (NAC) were administered with a similar psychedelic compound.
Lobe said its focus was to provide a therapeutic at sub-psychedelic dose levels for patients to be treated at home or in their physician’s office, avoiding long stays associated with other treatment modalities.
The company said delivering a non-hallucinatory dose of L-130 over several days would enable patients and their doctors the opportunity to maintain their normal routine during the treatment.
Lobe Sciences is a Vancouver-based life sciences company engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.
Contact the author Emily Jarvie at emily.jarvie@proactiveinvestors.com
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