Artelo Biosciences Announces Acceptance of ART26.12 into the National Institutes of Health’s “Preclinical Screening Platform for Pain” Program

Rhea-AI Summary

Artelo Biosciences (Nasdaq: ARTL) announced that its lead clinical FABP inhibitor, ART26.12, has been accepted into the NIH's Preclinical Screening Platform for Pain (PSPP) program, part of the HEAL Initiative. The PSPP program evaluates non-opioid assets in preclinical pain models and is open to researchers globally. The HEAL Initiative aims to address the overdose epidemic and pain crisis by improving prevention, treatment strategies, and pain management. Artelo previously received FDA clearance for first-in-human studies of ART26.12, with initial results expected in the first half of 2025.

Positive

• FDA clearance received for first-in-human studies of ART26.12
• Acceptance into NIH's PSPP program provides access to established preclinical pain models
• Initial study results expected in first half of 2025

Negative

• None.

Insights

Medical Research Analyst

The acceptance of ART26.12 into the NIH's PSPP program is a positive development, though its immediate financial impact is This preclinical screening initiative will provide valuable data on ART26.12's efficacy in pain management without significant cost to $3.6M market cap Artelo Biosciences. While the program aligns with the national priority to address the opioid crisis, investors should note that this is still an early-stage development, with first-in-human studies just beginning and results not expected until H1 2025.

The PSPP program's comprehensive evaluation across multiple pain models could accelerate ART26.12's development pathway and provide third-party validation. However, success in preclinical screening doesn't guarantee clinical trial success or eventual FDA approval. This development should be viewed as a foundation-building step rather than a near-term value driver.

SOLANA BEACH, Calif., Nov. 05, 2024 (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, dermatologic and neurological conditions, today announced that ART26.12, the Company’s lead clinical FABP inhibitor, has been accepted into the NIH Helping to End Addiction Long Term (HEAL) Initiative’s Preclinical Screening Platform for Pain (PSPP).

The HEAL Initiative is an NIH-wide effort to accelerate scientific solutions to the overdose epidemic, including opioid and stimulant use disorders, and the crisis of pain. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit: https://heal.nih.gov.

The PSPP program, part of the NIH HEAL Initiative, evaluates non-opioid assets in a battery of established preclinical pain models. The PSPP program accepts small molecules, biologics, devices, or natural products for evaluation, from researchers in academia and industry worldwide. For more information, visit: https://heal.nih.gov/research/preclinical-translational/screening-platform.

The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

“Access to the PSPP program will advance our understanding and development of ART26.12,” commented Saoirse O’Sullivan, PhD, Vice President Translational Science at Artelo Biosciences. “We are most gratified to be recognized and accepted into the PSPP Program.”

Artelo previously announced that the U.S. Food and Drug Administration (FDA) notified the Company that the first-in-human study with ART26.12 may proceed. Initial study results are expected during first half of 2025.

About ART26.12
Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids including endocannabinoids and fatty acids. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. ART26.12, Artelo’s lead FABP inhibitor, is a potent and selective inhibitor of FABP5 being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic, with initial clinical development planned for chemotherapy-induced peripheral neuropathy (CIPN). Beyond ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs have shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, dermatologic conditions, and anxiety disorders. The Company recently received FDA clearance of its Investigational New Drug application for ART26.12, for the treatment of CIPN.

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 Twitter: @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

When will Artelo Biosciences (ARTL) release initial results for ART26.12 human trials?

Artelo Biosciences expects to release initial results from the first-in-human study of ART26.12 during the first half of 2025.

What is the significance of ARTL's acceptance into the NIH's PSPP program?

Acceptance into the PSPP program allows Artelo to evaluate ART26.12 in established preclinical pain models, advancing their understanding and development of the drug as a non-opioid pain treatment.

Has Artelo Biosciences (ARTL) received FDA approval for ART26.12 trials?

Yes, the FDA has notified Artelo Biosciences that the first-in-human study with ART26.12 may proceed.