- Lobe Sciences Ltd. (LOBE) has announced clinical and development plans for the rest of 2022 and into early 2023
- The company said it has developed its initial Phase 1 study plan to demonstrate the safety and dosage for its proprietary new chemical entity
- Lobe Sciences has also acquired a new chemical entity that is expected to enter preclinical toxicity trials in late 2022 or early 2023
- The company also expects to submit a pre-IND meeting request with the FDA in Q3 2023
- Shares of Lobe Sciences are unchanged at C$0.05
Lobe Sciences Ltd. (LOBE) has shared its clinical and development plans for the rest of 2022 and early 2023.
The Vancouver, BC-based company, which is focused on discovering and developing psychedelic-derived medicines, said it has developed its initial Phase 1 study plan aimed to demonstrate the safety and dosing range for its proprietary new chemical entity, L-130.
Lobe Sciences said the Phase 1 study will evaluate the safety of L-130 in healthy volunteers in a single dose trial, which will be followed by a second Phase 1 trial that will evaluate longer-term use of the drug candidate in a multiple ascending dose (MAD) study.
When an appropriate dosing level has been reached and has no hallucinatory effects, the company said it will conduct a third and final safety study in patients evaluating both pharmacokinetics and a preliminary efficacy at a predetermined dose.
Lobe Sciences said it has also acquired a new chemical entity, L-131, which the company anticipates entering into preclinical toxicity trials later this year or early 2023.
“L-130 and L-131 are unique synthetic analogues of psilocin, the active metabolite of natural psilocybin, a substance extracted from a species of psychedelic mushroom. We have designed a regulatory development strategy to support the registration of these new chemical entities with the U.S. Food and Drug Administration (FDA),” Philip Young, CEO of Lobe Sciences, said in a press release. “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.”
The company said it also intends to submit a pre-IND meeting request with the FDA in Q3 2023 which, upon the response from the FDA to the company’s questions, will file its investigational new drug application. This will then allow the company to proceed with its initial clinical study later in 2022 or early 2023.
Shares of Lobe Sciences remain unchanged at C$0.05.