Lobe Sciences Ltd (CSE:LOBE, OTCQB:LOBED) said it has received regulatory clearance to conduct a Phase 1 study evaluating the safety and pharmacokinetics of a fixed dose of its proprietary psilocin-based compound L-130.
The company said in a statement that the initial Phase 1 clinical trial will utilize Clearway Global's network of contract research organizations and it believes that its first subject will enter the first trial in December and topline data will be available for review early in the first quarter of 2023.
Data will include safety and pharmacokinetic characteristics of L-130 and psychedelic properties if any, Lobe said.
READ: Lobe Sciences completes production of psilocin analogues for use in clinical trials
A second Phase 1 trial is scheduled for the first quarter of 2023 and will accurately assess the therapeutic window for the subsequent Phase 2a trial planned to follow, the company added.
As previously announced, the company said it is partnered with contract research organization iNGENu to finalize and conduct the Phase 2a protocol in Australia.
The company expects the first patient will be dosed in its Phase 2 trial in 2Q or 3Q 2023 and said it will provide updates as it finalizes plans for this program.
Upcoming trials
Lobe CSO Maghsoud Dariani said the company had multiple new chemical entities including L-130 entering human trials and L-131 entering pre-clinical trials as it prepares a pediatric Orphan Drug Application with the potential of receiving a Priority Review Voucher for L-131.
“All of this positions Lobe Sciences among the leaders in the small group of companies who are in clinical development of psychedelic drugs,” Dariani said.
Lobe CEO Philip J Young said added: "It is important to remember that we are approaching the development of a global commercial market with a disruptive approach to treating anxiety conditions with sequential sub-psychedelic dosing of our compounds.”
“Since the majority of patients with anxiety-related conditions are cared for by their personal family physician our goal is to create a treatment regimen that is effective and easily prescribed by the patient's personal physician,” he continued.
Lobe Sciences is a life sciences company focused on practical psychedelic medicines. Through collaborations with industry-leading partners, the company is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.
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