New Independent Review Paper Strengthens Therapeutic Rationale for Artelo’s FABP Inhibitor Program in Anxiety and Depression
- Independent peer-reviewed publication validates therapeutic potential of FABP inhibitors
- Phase 1 trial enrollment completed with nearly 50 healthy volunteers
- Multiple data readouts expected in near term (this quarter and summer)
- Treatment potentially offers benefits without cognitive side effects seen in current standard of care
- None.
Insights
A new scientific review validates Artelo's FABP inhibitor approach for anxiety/depression treatment, with Phase 1 data coming this quarter.
The publication of this peer-reviewed paper in Neurobiology of Disease represents a meaningful scientific validation for Artelo's FABP inhibitor platform. The review specifically highlights how FABP inhibition can modulate key neurological mechanisms involved in anxiety and depression, providing critical third-party support for Artelo's therapeutic approach.
Particularly significant is the review's focus on FABP5, which is the primary target of Artelo's lead compound ART26.12. The research suggests this mechanism could offer substantial advantages over current treatments by elevating anandamide levels without the cognitive side effects typically associated with existing therapies - potentially addressing a major unmet need in psychiatric medicine.
The timing is notable as Artelo has completed enrollment for its Phase 1 Single Ascending Dose study with nearly 50 healthy volunteers, with data expected this quarter. Additionally, results from a food effect study are anticipated this summer. These clinical milestones will be crucial in determining whether ART26.12's theoretical advantages translate to human subjects.
For a small biotech company like Artelo, scientific validation through peer-reviewed literature strengthens their position in discussions with potential partners and regulatory bodies. Their diversified pipeline targeting lipid-signaling pathways across multiple indications (cancer, pain, dermatological and neurological conditions) provides multiple potential pathways to value creation if their approach proves successful in clinical development.
SOLANA BEACH, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological or neurological conditions, today welcomed the publication of a comprehensive review in Neurobiology of Disease, titled “Fatty acid binding proteins and their involvement in anxiety and mood disorders,” that underscores the therapeutic potential of Fatty Acid Binding Protein (FABP) inhibitors in treating mood and anxiety disorders.
The peer-reviewed article was co-authored by Doctor Steven Laviolette, Professor in the Schulich School of Medicine along with other researchers from the University of Western Ontario, Canada, details extensive preclinical evidence supporting FABP5, FABP3, and FABP7 as key regulators of lipid trafficking, neuroinflammatory signaling, and endocannabinoid tone — mechanisms critically involved in the pathophysiology of anxiety and depression.
“We believe this paper provides compelling evidence that inhibition of FABP5 can significantly elevate anandamide levels, modulate stress-related neurocircuits, and produce robust anxiety-reducing and antidepressant effects without the cognitive side effects typically seen with current standard of care,” said Gregory D. Gorgas, Chief Executive Officer at Artelo Biosciences. “These findings add to the growing body of research supporting FABPs as promising targets for the treatment of wide array of neuropsychiatric conditions.”
Artelo’s proprietary FABP inhibitor platform, including its clinical-stage candidate ART26.12 as well as several back-up and follow-on leads from the same chemical series, selectively targets FABP5 and are designed to elevate endogenous anandamide and related lipid signaling molecules. A Phase 1 Single Ascending Dose study in nearly 50 healthy volunteers with ART26.12 has completed enrollment with data announcements expected this quarter. Artelo also expects to report results from a food effect study with ART26.12 this summer.
About ART26.12
ART26.12, Artelo’s lead FABP5 inhibitor, is being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic. Data from the first Phase 1 trial with ART26.12 is anticipated in Q2 2025. The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN). FABPs are a family of intracellular proteins that chaperone lipids important to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in several pathologies. In addition to ART26.12 in CIPN, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders.
About Artelo Biosciences
Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the Company applies leading-edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and X: @ArteloBio.
Forward Looking Statements
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Investor Relations Contact:
Crescendo Communications, LLC
Tel: 212-671-1020
Email: ARTL@crescendo-ir.com
FAQ
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