Lobe Sciences Ltd (CSE:LOBE, OTCQB:LOBED) said it expects to have two active Investigational New Drug applications in progress with the US Food and Drug Administration (FDA) by the year-end for its new chemical entities (NCEs) derived from psychedelic compounds L-130 and L-131.
In an updated 2023 overview, the company noted its progress in 2022 which included inking research collaborations with contract research organizations and commencing a Phase 1 pharmacokinetics program to ascertain the bioavailability and metabolism of L-130.
Patient enrollment in this trial, the first of three similar trials that will determine the highest concentration of this NCE without a hallucinogenic effect, is expected to begin in early 2023, Lobe noted.
READ: Lobe Sciences provides update on clinical development of its proprietary psilocin compound L-130
In anticipation of successfully identifying the highest dose having a minimal or no hallucinogenic effect, the company has begun preparing a Phase 2 protocol utilizing that dose, with the company expecting a US IND filing for L-130 during 2023.
Regarding L-131, Lobe noted that the synthesis of this NCE has produced sufficient material for preclinical investigation in a pediatric neurological orphan drug application.
The company expects to file an Orphan Drug Designation and Priority Review Application to the FDA following this preclinical investigation, to be followed by preclinical safety and toxicokinetic studies late in the first half or early in the second half of the year.
An IND filing for L-131 is expected in the second half of the year, Lobe added.
Lobe CEO Philip Young said the company’s plans for 2023 were “ambitious but doable”.
“By year-end, we should have two active INDs, one of which may be designated as an orphan drug and an ongoing Phase II trial assessing L-130 as a therapeutic to treat a refractive neurological disorder. We will release details of each of these trials and the indication being treated as our patents are published," he added.
Lobe Sciences is a biopharmaceutical company focused on developing patient-friendly practical psychedelic medicines.
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