Artelo Biosciences to Showcase First-in-Human FABP5 Inhibitor ART26.12 as a Novel Approach to Pain Treatment at IASP 2026 World Congress on Pain
In a four-week nonclinical osteoarthritis study, ART26.12 reduced pain comparably to naproxen, with significantly less stomach tissue damage.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Artelo Biosciences (ARTL) plans to present ART26.12 pain-treatment data at the IASP World Congress on Pain on October 29, 2026. Professor Saoirse O’Sullivan will present the program in Bangkok, Thailand. ART26.12 is an investigational inhibitor of fatty acid binding protein 5, initially targeting chemotherapy-induced peripheral neuropathy, or nerve damage.
The Phase 1 single ascending dose study reported no serious adverse events attributed to ART26.12 and predictable drug exposure proportional to dose. Preliminary food-effect results supported potential administration with or without food. Nonclinical studies showed activity across several pain models. Artelo is preparing to initiate a Phase 1 multiple ascending dose study in the fourth quarter of 2026 and has initiated steps toward enrollment.
Positive
- Minor pointPhase 1 single-dose results showed no serious adverse events attributed to ART26.12 and a wide estimated safety margin.
- Minor pointPhase 1 drug exposure was predictable and proportional to dose.
- Minor pointPreliminary food-effect results supported potential ART26.12 administration in fed or fasted conditions.
- Minor point. Forward-looking: it has not happened yet and may not happen.Phase 1 multiple ascending dose study is planned for the fourth quarter of 2026; enrollment preparations have begun.
- Minor pointNonclinical neuropathy studies showed potential to treat diabetes- or chemotherapy-associated pain and prevent neuropathy alongside paclitaxel or oxaliplatin.
2 minor points
- Minor pointNonclinical pain models demonstrated analgesic activity in cancer-induced bone pain and spinal cord injury.
- Minor pointFour-week nonclinical osteoarthritis study showed pain reduction comparable to naproxen, with significantly less stomach tissue damage.
Negative
- None.
Details
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Key Figures
- Planned multiple ascending dose study
- Q4 2026
- Phase 1 ART26.12 study; planned initiation
Key Terms
fatty acid binding protein 5 medical
multiple ascending dose medical
pharmacokinetics medical
chemotherapy-induced peripheral neuropathy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Presentation will introduce ART26.12, the first selective FABP5 inhibitor to enter human clinical studies, to the world’s largest gathering of pain professionals
Growing body of data supports ART26.12’s potential as a novel, non-opioid treatment for pain as the Company advances toward a multiple ascending dose (MAD) study
SOLANA BEACH, Calif., Oct. 26, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with obesity, cancer, pain, dermatologic and neurological conditions, today announced that Professor Saoirse O’Sullivan is scheduled to present data on the ART26.12 program at the IASP 2026 World Congress on Pain, taking place October 26–30, 2026, in Bangkok, Thailand.
Organized by the International Association for the Study of Pain (IASP), the World Congress on Pain is the largest global gathering of pain professionals, bringing together thousands of scientists, clinicians and healthcare providers from around the world. Professor Saoirse O'Sullivan, Vice President of Translational Sciences at Artelo, plans to present data from Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor program entitled “ART26.12; a Peripherally Acting, Non-Opioid, Non-Steroidal Analgesic for Peripheral Neuropathy” on October 29, 2026. During the congress, Professor O’Sullivan is also scheduled to meet with leaders in the pain field to discuss ART26.12’s potential as a novel non-opioid therapeutic approach for pain.
“With the urgent need for effective alternatives to opioids, we believe ART26.12 represents a promising new approach to pain management as the first selective FABP5 inhibitor to advance into human clinical trials,” said Professor O’Sullivan. “Presenting our growing body of data at the prestigious World Congress on Pain provides an important opportunity to engage directly with leading clinicians, researchers and key opinion leaders in the field, share our progress and explore the potential of this novel mechanism to address significant unmet needs in pain treatment.”
ART26.12 – A Novel Approach to Non-Opioid Pain Treatment
- Novel mechanism: ART26.12 is a potential first-in-class, orally administered, peripherally acting, selective FABP5 inhibitor being developed as a non-opioid, non-steroidal analgesic, initially targeting chemotherapy-induced peripheral neuropathy (CIPN).
- Chemotherapy and diabetic neuropathy: Across multiple nonclinical studies, ART26.12 demonstrated potential to treat painful neuropathies associated with diabetes or chemotherapy and to prevent chemotherapy-induced peripheral neuropathy when administered alongside paclitaxel or oxaliplatin.
- Broader pain applications: Nonclinical research has also demonstrated analgesic activity in models of cancer-induced bone pain and spinal cord injury, supporting investigation across multiple chronic pain conditions.
- Osteoarthritis findings: In a four-week nonclinical osteoarthritis study, oral ART26.12 reduced pain comparably to naproxen, while treated animals exhibited significantly less stomach tissue damage.
- Positive first-in-human data: The Phase 1 single ascending dose study reported a favorable safety profile with no serious adverse events attributed to ART26.12, a predictable dose-proportional pharmacokinetics, and a wide estimated safety margin. Preliminary food-effect results supported the potential for administration in fed or fasted conditions.
- Next clinical milestone: Artelo is preparing to initiate a Phase 1 multiple ascending dose (MAD) study in the fourth quarter of 2026.
“ART26.12 has demonstrated promising analgesic activity across multiple nonclinical models of pain, including chemotherapy-induced peripheral neuropathy, while our Phase 1 results have provided encouraging safety and pharmacokinetic data in humans,” said Professor O’Sullivan. “Together, these findings strengthen our confidence in the potential of FABP5 inhibition as a differentiated, non-opioid approach to pain management with a promising safety profile. We have initiated steps to begin enrollment to our multiple ascending dose study, the next clinical development step planned for ART26.12.”
About ART26.12
ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy. Human studies with ART26.12 have demonstrated a favorable safety profile with no serious adverse events, as well as predictable, linear pharmacokinetics and dosing flexibility in both fed and fasted states. Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. In addition to ART26.12, 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, with a diversified pipeline addressing significant unmet needs in obesity, anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by an experienced executive team collaborating with world-class researchers and technology partners, Artelo applies rigorous scientific, regulatory, and commercial expertise to maximize stakeholder value. 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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, 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 or partnering 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 but not limited to: our ability to raise additional capital in the future; the inherent uncertainties of preclinical and clinical research, including the possibility that results observed in nonclinical animal models may not be predictive of, or replicated in, human clinical trials; the uncertainty of patent protection and the potential for intellectual property challenges; the highly competitive nature of the pharmaceutical industry, including the market for pain therapeutics; the risk that third-party market projections may not materialize or that the Company may not be able to participate in projected market opportunities; the timing, content and availability of the Company’s presentation at the IASP 2026 World Congress on Pain; and our ability to enter into partnering or licensing arrangements on acceptable terms, or at all. Readers 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
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Artelo’s ART26.12 first-in-human study show?
The Phase 1 single ascending dose study reported no serious adverse events attributed to ART26.12, predictable drug exposure proportional to dose, and a wide estimated safety margin. Preliminary food-effect results supported the potential for dosing in fed or fasted conditions.
When does Artelo plan to begin the next ART26.12 clinical study?
Artelo is preparing to initiate a Phase 1 multiple ascending dose study in the fourth quarter of 2026. The company has initiated steps to begin enrollment.