Artelo Biosciences Announces Publication of New Peer-Reviewed Research Demonstrating ART26.12’s Effectiveness in Treating Psoriasis

Rhea-AI Summary

Artelo Biosciences (Nasdaq: ARTL) has published new research in the Journal of Investigative Dermatology demonstrating the effectiveness of ART26.12, their FABP5 inhibitor, in treating psoriasis. The study shows that ART26.12, an orally active small-molecule drug, achieved comparable results to immunomodulatory drugs in both in vitro and in vivo psoriasis models.

The research highlights that FABP5, first discovered in psoriasis tissue in the 1990s, is highly expressed in skin and immune cells and plays a important role in skin cell homeostasis. Pre-clinical studies suggest ART26.12 may offer a less costly and safer treatment approach for psoriasis compared to existing options.

The company has completed enrollment for its Phase 1 Single Ascending Dose study of ART26.12 in healthy volunteers, with data expected to be announced in the current quarter.

Positive

• Successful completion of Phase 1 trial enrollment
• Demonstrated efficacy comparable to existing treatments in preclinical studies
• Potential for better safety profile based on pre-clinical data
• Publication in prestigious peer-reviewed journal validates research

Negative

• Still in early clinical stages with no human efficacy data yet
• Faces competition from established immunomodulatory drugs

ART26.12 Phase 1 in healthy volunteers completes enrollment with clinical data announcement expected this quarter

SOLANA BEACH, Calif., April 28, 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 new research published in the peer-reviewed Journal of Investigative Dermatology describing the positive effects of ART26.12 in both in vitro and in vivo psoriasis models, showing results comparable to immunomodulatory drugs with known serious adverse events.

The research article, titled “ART26.12, A FATTY ACID-BINDING PROTEIN 5 INHIBITOR, SHOWS EFFICACY IN PRECLINICAL PSORIASIS MODELS,” highlights ART26.12, Artelo’s orally active, small-molecule inhibitor of Fatty Acid Binding Protein 5 (FABP5) and its potential ability to treat psoriasis.

George Warren, PhD, Lead Author and Principal Scientist at Artelo, said, “We are excited to share the results on this novel target in psoriasis. Our findings demonstrate that ART26.12 has effects comparable to powerful immunomodulators, while its unique pharmacology leads to a significantly distinct expression of proteins and lipids in the skin.”

FABP5, sometimes referred to as epidermal FABP, was first discovered in psoriasis tissue in the early 1990s. It is highly expressed in skin and immune cells and plays a key role in skin cell homeostasis. FABP5 is upregulated in numerous dermatological conditions, promoting inflammation and correlating with disease severity.

Dr. Warren added, “Pre-clinical IND-enabling studies with ART26.12, supported by a literature review of greater than 300 studies examining FABP inhibition, imply a low toxicological risk for ART26.12, which, if borne out in clinical studies, suggest FABP5 inhibition with an orally delivered small molecule may be an attractive, less costly, and safer approach for treating this debilitating chronic disease.”

A Phase 1 Single Ascending Dose study in healthy volunteers with ART26.12 has completed enrollment with data announcements expected this quarter.

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 Psoriasis
Psoriasis is a chronic autoimmune condition that accelerates the production of skin cells, leading to the formation of red, scaly patches. Affecting about 2–3% of the global population, Psoriasis can occur anywhere on the body, most commonly on the scalp, elbows, and knees. Psoriasis is a lifelong condition, and while its severity varies, it can significantly impact quality of life through physical discomfort and emotional distress. Flare-ups are often triggered by factors such as stress, infections, or environmental changes. In addition to the visible symptoms, psoriasis is associated with a higher risk of other health issues, including cardiovascular disease. There is no cure for psoriasis, and current treatments, while broadly effective, can have significant side effects, highlighting the need for safer, more effective therapies. According to Fortune Business Insights, the global psoriasis market was estimated to be valued at $27.2 billion in 2024, and is expected to grow from $29.15 billion in 2025 to $57.68 billion by 2032.

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 statement 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' ART26.12 psoriasis research?

ART26.12 showed effectiveness comparable to immunomodulatory drugs in psoriasis models, with a potentially better safety profile and lower cost due to its unique mechanism targeting FABP5.

When will ARTL release the Phase 1 clinical trial results for ART26.12?

Artelo Biosciences expects to announce data from the Phase 1 Single Ascending Dose study in healthy volunteers during the current quarter of 2025.

How does Artelo's ART26.12 differ from current psoriasis treatments?

ART26.12 is an orally active small-molecule FABP5 inhibitor that may offer a safer and more cost-effective alternative to current immunomodulatory drugs.

What is the significance of FABP5 in psoriasis treatment?

FABP5, discovered in psoriasis tissue in the 1990s, is highly expressed in skin and immune cells, playing a key role in skin cell homeostasis and inflammation in dermatological conditions.