EXCLUSIVE: Artelo Biosciences Concludes First Cohort Of Healthy Volunteers Of FABP Inhibitor Program

On Monday, Artelo Biosciences Inc ARTL completed a safety review of the first cohort of eight healthy volunteers in the company's Phase 1 study of ART26.12. 

ART26.12 is the lead compound in Artelo's proprietary Fatty Acid Binding Protein (FABP) platform and is believed to be the first-ever selective FABP5 inhibitor to enter clinical trials.

FABPs are a family of intracellular proteins that chaperone lipids essential to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in several pathologies. 

In development as a non-opioid approach to the management of painful neuropathies, ART26.12 has already demonstrated significant promise in multiple preclinical pain models, including chemotherapy-induced peripheral neuropathy, diabetic neuropathy, cancer bone pain, and osteoarthritis.

Based on the safety profile of ART26.12 in preclinical studies, the company looks forward to learning from the initial safety, pharmacokinetic, and biomarker data from this ongoing human study, which is expected to be completed during the first half of 2025.

With dosing already underway, the next cohort in the Phase 1 study will provide additional insight into the development.

Results from the current Phase 1 single ascending dose study are intended to determine the most suitable doses of ART26.12 to utilize in a multiple ascending dose study evaluating ART26.12 in healthy volunteers planned for the second half of 2025.

In December, Artelo Biosciences announced the presentation of preliminary data on ART27.13, a benzimidazole derivative being studied for cancer-related anorexia.

Artelo is evaluating ART27.13 in the Phase 1/2 trial in cancer-related anorexia, which is currently enrolling Phase 2 of the study.

In Phase 1, ART27.13 was orally administered at 150 to 650 microgram doses.

The investigational drug was well tolerated, with only mild to moderate adverse events observed in a minority of participants.

At one month of treatment, two-thirds of participants showed evidence that the drug was impacting their weight loss, with either stabilization or reversal of weight loss associated with their cancer.

Phase 2 is accruing participants at a 650 microgram dosage with planned escalation at 4-week intervals up to a dose of 1300 micrograms per day. The study is expected to complete enrollment during the first half of 2025.

Price Action: ARTL stock closed at $1.16 on Monday.

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