Press Releases April 20, 2026 07:50 AM

Artelo Announces Peer-Reviewed Publication Supporting its FABP5 Inhibitor ART26.12 as a Novel Pain Treatment with a Potentially First-in-Class Profile

Peer-reviewed study supports ART26.12, a novel FABP5 inhibitor, as a promising non-opioid pain treatment ahead of planned clinical trials.

By Caleb Monroe ARTL
Artelo Announces Peer-Reviewed Publication Supporting its FABP5 Inhibitor ART26.12 as a Novel Pain Treatment with a Potentially First-in-Class Profile
ARTL

Artelo Biosciences announces publication of peer-reviewed research demonstrating the analgesic potential of its FABP5 inhibitor ART26.12 across multiple pain models, highlighting a differentiated mechanism with a favorable safety profile from Phase 1 studies. The company plans to initiate multiple ascending dose trials later this year to advance clinical development of this novel, non-opioid analgesic candidate.

Key Points

  • Peer-reviewed publication validates FABP5 inhibition as a novel mechanism for pain management with ART26.12 showing efficacy across visceral, inflammatory, neuropathic, and joint pain models.
  • Phase 1 single ascending dose study showed excellent safety and tolerability of ART26.12, with zero adverse events attributed to the drug.
  • Planned multiple ascending dose clinical trial to further evaluate ART26.12 in 2026, targeting a large unmet need for non-opioid, well-tolerated pain therapies impacting pharmaceutical and healthcare sectors.

Demonstrates ART26.12’s Differentiated Profile as a Promising Pain Treatment Ahead of Planned Multiple Ascending Dose Study This Year

Phase 1 SAD Study Exhibited Excellent Safety with Zero Adverse Events Attributed to ART26.12

SOLANA BEACH, Calif., April 20, 2026 (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 the publication of a peer‑reviewed article titled “Evaluating fatty acid-binding protein 5 (FABP5) as a therapeutic target for pain management” in the European Journal of Pain, an internationally recognized journal in pain research.

The article discusses preclinical evidence showing that FABP5 inhibition produced analgesic effects across multiple pain models, including visceral, inflammatory, neuropathic, and joint pain. The publication also highlights evidence that FABP5 inhibition may influence several established pain-related pathways while reducing pro-inflammatory mediators, supporting its potential as a differentiated, non-opioid therapeutic approach.

These findings are supported by a broader body of evidence – specifically for ART26.12 – from seven prior preclinical studies in diabetic neuropathy, osteoarthritis, cancer bone pain, and peripheral neuropathy caused by chemotherapy. ART26.12 demonstrated consistent analgesic activity across each model and validated FABP5 as a novel lipid-signaling target for pain treatment.

“This peer-reviewed publication strengthens the scientific foundation for ART26.12 and reinforces our view that FABP5 inhibition represents a novel mechanism of action with the potential to redefine the treatment of pain,” stated Dr. Andrew Yates, Artelo’s Chief Scientific Officer. “Importantly, ART26.12 with a potentially first-in-class profile has demonstrated what we believe to be a highly differentiated approach for the treatment of pain. In our completed Phase 1 single ascending dose study, ART26.12 was well-tolerated, with no severe or serious drug-related adverse events presented for all doses evaluated. We believe ART26.12 has tremendous potential as an effective and well-tolerated therapy in a space where safety remains a critical limitation. We are now advancing ART26.12 into a planned multiple ascending dose study this year as the next step in its clinical development.”

Novel, non-opioid, and better tolerated pain treatments remain an area of significant unmet need, particularly for patients seeking alternatives to opioids and NSAIDs. According to the CDC, 24.3% of U.S. adults experienced chronic pain in 2023, while the FDA has highlighted the serious risks associated with opioid analgesics, including misuse, addiction, overdose, and death.

“Preclinical data across multiple pain modalities strongly support FABP5 as a promising target for non‑opioid and non‑steroidal pain relief,” said Dr. William George Warren, Principal Scientist at Artelo and lead author of the publication. “These findings strengthen the rationale for advancing selective FABP5 inhibitors, such as ART26.12, toward clinical development for the treatment of pain.”

Artelo continues to advance a diversified portfolio of selective, dual, and pan FABP inhibitors – including programs targeting FABP5 – to pursue therapeutic opportunities in pain and other indications driven by dysregulated lipid signaling.

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 anorexia, cancer, anxiety, dermatologic conditions, pain, inflammation, and diseases of the eye. Led by an experienced executive team collaborating with world-class researchers and technology partners, Artelo applies rigorous scientific, regulatory, and commercial, discipline 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 and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the Company's plans and expectations. These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied by such statements, including market and other conditions. All statements that are not historical facts are forward-looking statements, including but not limited to, statements regarding: the use of proceeds from the offering and the potential exercise of the warrants. For a discussion of risks and uncertainties, please refer to the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K. The Company undertakes no obligation to publicly update any forward-looking statement, except as required by applicable securities laws.

Investor Relations Contact:
Crescendo Communications, LLC
Tel: 212-671-1020
Email: [email protected]


Risks

  • Clinical development risks including potential failure to demonstrate efficacy or safety in upcoming multiple ascending dose studies.
  • Market competition from existing pain management therapies including opioids, NSAIDs, and other novel analgesics could affect commercial success.
  • Regulatory risks related to approval timelines, data requirements, and potential post-market surveillance impacting biotech and pharmaceutical industries.

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