Latest news with #FattyAcidBindingProtein5
Associated Press
30-06-2025
- Business
- Associated Press
Artelo Biosciences Announces Positive First-in-Human Data for ART26.12, a Novel Non-Opioid Treatment Candidate for Persistent Pain
First Orally Active Fatty Acid Binding Protein 5 Inhibitor Evaluated in Humans First-in-Class Approach Targets Unmet Need in Multibillion-Dollar Pain Management Market SOLANA BEACH, Calif., June 30, 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 favorable results from its first-in-human study evaluating ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5). The results affirm the promising safety and pharmacokinetic (PK) profile previously observed in preclinical studies. Inhibiting FABP5 represents a unique mechanism of action with ART26.12 standing out as a first-in-class candidate in the field of pain management. The Phase 1 Single Ascending Dose (SAD) study was designed to assess the safety, tolerability, and pharmacokinetics of ART26.12 in healthy volunteers. The SAD study enrolled 49 subjects. The key findings include: Andrew Yates, Ph.D., Senior Vice President and Chief Scientific Officer at Artelo, commented, 'We are greatly encouraged with the results of the SAD study with our lead FABP5 inhibitor and we are particularly pleased to observe that the safety and PK profile that had been generated from ART26.12's non-clinical studies translated well to the human experience.' ART26.12 is the first orally administered, selective, and peripherally restricted FABP5 inhibitor to enter human clinical evaluation. By targeting FABP5, ART26.12 modulates endogenous lipid signaling molecules that exert analgesic effects through established pathways, including TRPV1, PPAR alpha, and cannabinoid receptors, with additional mechanisms such as Nav1.8 under investigation. The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is expected to surpass $159 billion by 20301, driven by the increasing prevalence of conditions such as neuropathic pain, arthritis, and fibromyalgia. Despite the scale of the market, innovation remains sparse—particularly for non-opioid therapies. As part of the U.S Food and Drug Administration's Overdose Prevention Framework, the Agency has issued draft guidance aimed at encouraging the development of non-opioid analgesics for pain. ART26.12 is positioned to fill this gap with an innovative mechanism of action and favorable safety profile. A Multiple Ascending Dose study to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing over time is expected to commence in the fourth quarter this year. About ART26.12 ART26.12, Artelo's lead FABP5 inhibitor, is being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic. 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, anxiety disorders, and psoriasis. ART26.12 has been included in Helping to End Addiction Long-term® (HEAL) Initiative's Preclinical Screening Platform for Pain program of the U.S. National Institutes of Health. The HEAL program is dedicated to advancing non-opioid solutions to pain and curbing opioid use disorder. 1 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 and X: @ArteloBio. Forward-Looking StatementsInvestor Relations Contact: Crescendo Communications, LLC Tel: 212-671-1020 Email: [email protected]
Yahoo
28-04-2025
- Business
- Yahoo
EXCLUSIVE: Artelo Biosciences' New Peer-Reviewed Research Shows Effectiveness Of Psoriasis Candidate In Animal Models
Artelo Biosciences, Inc. (NASDAQ:ARTL) on Monday 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. The research shows results comparable to immunomodulatory drugs with known serious adverse events. The research highlights ART26.12, Artelo's orally active, small-molecule inhibitor of Fatty Acid Binding Protein 5 (FABP5), and its potential ability to treat 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.' 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, and data announcements are expected in the second quarter of 2025. The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN). In addition to ART26.12 in CIPN, Artelo's extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. In January, Artelo Biosciences completed a safety review of the first cohort of eight healthy volunteers in the company's Phase 1 study of ART26.12. In December, Artelo Biosciences announced the presentation of preliminary data on ART27.13, a benzimidazole derivative being studied for cancer-related anorexia. Artelo is evaluating ART27.13 in the Phase 1/2 trial in cancer-related anorexia, which is currently enrolling Phase 2 of the study. In Phase 1, ART27.13 was orally administered at 150 to 650 microgram doses. The investigational drug was well tolerated, with only mild to moderate adverse events observed in a minority of participants. At one month of treatment, two-thirds of participants showed evidence that the drug was impacting their weight loss, with either stabilization or reversal of weight loss associated with their cancer. Phase 2 is accruing participants at a 650 microgram dosage with planned escalation at 4-week intervals up to a dose of 1300 micrograms per day. Initial data from the Phase 2 CAReS trial is anticipated by the end of Q2 2025. Price Action: ARTL stock closed at $1.04 on Friday. Read Next:UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article EXCLUSIVE: Artelo Biosciences' New Peer-Reviewed Research Shows Effectiveness Of Psoriasis Candidate In Animal Models originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
