New Independent Review Paper Strengthens Therapeutic Rationale for Artelo’s FABP Inhibitor Program in Anxiety and Depression

Rhea-AI Summary

Artelo Biosciences (NASDAQ: ARTL) highlights a new independent review paper published in Neurobiology of Disease that validates their FABP inhibitor program for anxiety and depression treatment. The paper, co-authored by Dr. Steven Laviolette and researchers from the University of Western Ontario, provides evidence that FABP5, FABP3, and FABP7 are crucial in regulating lipid trafficking and neuroinflammatory signaling. Artelo's clinical-stage candidate ART26.12, which targets FABP5, has completed enrollment in a Phase 1 Single Ascending Dose study with nearly 50 healthy volunteers. The company expects to announce data this quarter and results from a food effect study this summer. The research suggests that FABP5 inhibition can increase anandamide levels and produce anxiety-reducing and antidepressant effects without typical cognitive side effects.

Positive

• 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

Negative

• None.

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

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission, including our ability to raise additional capital in the future. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable securities laws.

Investor Relations Contact:
Crescendo Communications, LLC
Tel: 212-671-1020
Email: ARTL@crescendo-ir.com

FAQ

What is the significance of the new review paper for Artelo Biosciences (ARTL)?

The paper validates Artelo's FABP inhibitor program by providing evidence that FABP5 inhibition can reduce anxiety and depression without cognitive side effects typically seen in current treatments.

What is the current development status of Artelo's ART26.12?

ART26.12 has completed enrollment in a Phase 1 Single Ascending Dose study with nearly 50 healthy volunteers, with data expected this quarter and food effect study results in summer 2025.

How does Artelo's FABP inhibitor treatment work?

The treatment works by selectively targeting FABP5 to elevate endogenous anandamide and related lipid signaling molecules, modulating stress-related neurocircuits.

What are the potential advantages of ARTL's FABP inhibitor over current anxiety treatments?

The treatment potentially offers anxiety-reducing and antidepressant effects without the cognitive side effects typically associated with current standard of care medications.

When will Artelo Biosciences (ARTL) release the next clinical data?

Artelo expects to announce Phase 1 Single Ascending Dose study data in Q2 2025 and food effect study results in summer 2025.