Artelo’s Fatty Acid Binding Protein 5 Inhibitor, ART26.12, Compares Favorably to Naproxen in an Osteoarthritis Pain Study

Rhea-AI Summary

Artelo Biosciences presented promising new data for its FABP5 inhibitor ART26.12 at the British Pain Conference, showing favorable comparison to naproxen in treating osteoarthritis pain. In a surgical rat model study, ART26.12 demonstrated dose-responsive analgesic effects that were sustained over 28 days, improving weight-bearing ability in affected limbs. The drug candidate, currently in human trials, is being developed as a non-opioid, non-steroidal treatment for chemotherapy-induced peripheral neuropathy and potentially chronic osteoarthritis pain. ART26.12's effectiveness matched naproxen, a first-line therapy known for serious side effects with chronic use. This development is significant given that osteoarthritis affects 606.9 million people globally, including 32 million in the U.S., causing chronic pain, reduced mobility, and decreased quality of life.

Positive

• ART26.12 showed similar effectiveness to naproxen, a proven first-line therapy
• Drug demonstrated sustained analgesic effects over 28 days in dose-responsive manner
• Potential market opportunity with 606.9 million global osteoarthritis patients
• Non-opioid and non-steroidal properties could offer advantages over existing treatments

Negative

• None.

Insights

Pharmaceutical Development Expert

Artelo's FABP5 inhibitor shows promising analgesic effects comparable to naproxen but potentially with better safety profile for osteoarthritis treatment.

The pre-clinical data for Artelo's ART26.12 represents a meaningful development in the pain management space. The drug showed dose-responsive efficacy in a surgical rat model of osteoarthritis, with sustained effects over a 28-day period – a significant observation that demonstrates durability of response. Most notably, ART26.12 demonstrated analgesic effects comparable to naproxen, a widely-used NSAID, but without explicitly mentioning the gastrointestinal, cardiovascular, and renal complications that typically limit long-term NSAID use.

The advancement to human trials marks a critical milestone, though it's important to note the initial development focus appears to be on chemotherapy-induced peripheral neuropathy rather than osteoarthritis. This suggests a strategic pathway that targets an unmet medical need first, potentially followed by expansion into the larger osteoarthritis market affecting over 606 million people globally.

The mechanism targeting Fatty Acid Binding Protein 5 represents a novel approach to pain management. FABP5 inhibition affects lipid signaling pathways involved in pain transmission, which differs substantially from traditional NSAIDs that target cyclooxygenase enzymes. This differentiated mechanism could potentially avoid the ceiling effect and safety limitations seen with current analgesics.

For a small clinical-stage company like Artelo, positive pre-clinical data in a condition as prevalent as osteoarthritis represents a significant value driver, especially if human trials confirm both efficacy and an improved safety profile compared to current standards of care.

SOLANA BEACH, Calif., June 05, 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 announced its presentation of new data at the British Pain Conference held in Newport, Wales, UK on June 3-5, 2025 (https://bpsasm.org/) that further validates the therapeutic potential of Fatty Acid Binding Protein (FABP) inhibitors in treating osteoarthritis (OA) pain.

Professor Saoirse O’Sullivan, Vice President of Translation Sciences at Artelo Biosciences, presented results from an animal study titled: “The Fatty Acid Binding Protein 5 Inhibitor ART26.12 is a Novel Analgesic for Osteoarthritis Pain.” The data builds upon an extensive set of pre-clinical data for ART26.12 that demonstrates analgesic and anti-nocicpetive effects in multiple models of pain.

Positive effects of ART26.12 were observed in a surgical rat model of osteoarthritis, in which either single or repeated oral doses of Artelo’s FABP5 inbitor increased the ability of rats to bear weight on the limb with OA out to four weeks.

Professor O’Sullivan stated, “ART26.12 was effective in a dose-responsive manner, with sustained and consistent effects over 28 days. The analgesic effect of ART26.12 was similar to naproxen, a proven first-line therapy which is often hampered by a number of serious side effects when taken chronically.”

Now undergoing human trials, ART26.12 is a novel, non-opioid, non-steroidal drug candidate initially in development for the prevention and treatment of peripheral neuropathy caused by common chemotherapy treatments with potential for development as an alternative for chronic OA pain.

OA is a progressive joint disease in which cartilage wears away over time, causing chronic pain, stiffness, swelling, and significant loss of mobility, especially in the knees, hips, hands, and spine. It affects approximately 606.9 million people globally, including over 32 million in the U.S., and can lead to disabling pain, reduced quality of life, and loss of independence, especially in advanced cases.

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, efficacy of the Company’s product candidates, results and conclusions from preclinical studies and clinical trials, 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 are the key findings of Artelo Biosciences (ARTL) ART26.12 osteoarthritis study?

The study showed ART26.12 was effective in treating osteoarthritis pain in a dose-responsive manner, with sustained effects over 28 days, comparable to naproxen but without the associated side effects of chronic use.

What conditions is Artelo's ART26.12 being developed to treat?

ART26.12 is primarily being developed for chemotherapy-induced peripheral neuropathy, with potential expansion into chronic osteoarthritis pain treatment.

How does ART26.12 compare to existing osteoarthritis treatments?

ART26.12 showed comparable effectiveness to naproxen, a first-line therapy, but as a non-opioid, non-steroidal treatment, it may avoid serious side effects associated with chronic naproxen use.

What is the market potential for Artelo's ART26.12?

The market potential is significant, with osteoarthritis affecting 606.9 million people globally, including 32 million in the U.S.

What stage of development is Artelo's ART26.12 currently in?

ART26.12 is currently undergoing human trials, following successful pre-clinical studies in animal models.