ART26.12 / Artelo Biosci, Stony Brook Medicine - LARVOL DELTA

Artelo Biosciences Announces Publication of New Peer-Reviewed Research Demonstrating ART26.12’s Effectiveness in Treating Psoriasis (GlobeNewswire) - "Artelo Biosciences, Inc...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....highlights ART26.12, Artelo’s orally active, small-molecule inhibitor of Fatty Acid Binding Protein 5 (FABP5) and its potential ability to treat psoriasis....A Phase 1 Single Ascending Dose study in healthy volunteers with ART26.12 has completed enrollment with data announcements expected this quarter."

P1 data • Preclinical • Psoriasis

ART26.12, A FATTY ACID-BINDING PROTEIN 5 INHIBITOR, SHOWS EFFICACY IN PRECLINICAL PSORIASIS MODELS. (PubMed, J Invest Dermatol) - "In vivo, ART26.12 (25 or 100 mg/kg BID) or BMS-986165 (TYK2 inhibitor; 10 mg/kg QD) were given orally for 10 days in the imiquimod mouse model. Lipidomic analysis showed widespread modulation including ceramides and linoleic acid derivatives. These data suggest ART26.12 may be a potential psoriasis treatment."

Journal • Preclinical • Dermatology • Immunology • Inflammation • Psoriasis • FABP5 • IL17A • IL22 • TYK2

Artelo Biosciences Provides Business Update and Reports Fiscal 2024 Year-End Financial Results (GlobeNewswire) - "ART26.12: Phase I study is on track for completion in Q2 2025. ART27.13: Initial data from the Phase 2 CAReS trial anticipated by the end of Q2 2025. ART12.11: Substantial progress has been made toward initiation of human studies with an oral solid dosage form in 2H 2025."

New trial • P2 data • Trial completion date • Anorexia • CNS Disorders • Pain

Artelo Biosciences Announces Successful Completion of First Cohort in a Phase 1 Study of ART26.12 (GlobeNewswire) - "Artelo Biosciences...today announced the completed safety review of the first cohort of eight healthy volunteers in the Company’s Phase 1 study of ART26.12.... ART26.12 has already demonstrated significant promise in multiple preclinical pain models including, Chemotherapy Induced Peripheral Neuropathy (CIPN), Diabetic Neuropathy, cancer bone pain and osteoarthritis....Results from the current Phase 1 single ascending dose study are intended to determine the most suitable doses of ART26.12 to utilize in a multiple ascending dose study evaluating ART26.12 in healthy volunteers planned for the second half of 2025."

P1 data • Trial status • Pain

A novel Fatty Acid Binding Protein 5 (FABP5) inhibitor shows efficacy in preclinical models of psoriasis (EADV 2024) - "In vivo , male Balb/C mice were given either vehicle, BMS-986165 (Deucravacitinib, tyrosine kinase 2 inhibitor) (10 mg/kg p.o. QD) , or ART26.12 (25 or 100 mg/kg p.o. BID) for two days prior to application of imiquimod (IMQ, 62.5 mg of a 5% cream for 7 days on their back) , and throughout IMQ treatment. In* models of skin inflammation, The FABP5 inhibitor ART26.12 had a positive effect on in vitro gene profiling and attenuated the effects of IMQ in vivo . These data suggest that ART26.12 shows promise as a novel oral treatment for psoriasis, and possibly other dermatological conditions where FABP5 is also known to be elevated."

Preclinical • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • CXCL10 • CXCL8 • FABP5 • IL17A • IL1R1 • IL22 • KRT10 • KRT14 • PIAS4 • SOCS3 • TLR2 • TNFA • TP63 • TYK2

Potential safety implications of fatty acid-binding protein inhibition. (PubMed, Toxicol Appl Pharmacol) - "Recently, a potent, selective FABP5 inhibitor (ART26.12), with 90-fold selectivity to FABP3 and 20-fold selectivity to FABP7, was found to be remarkably benign, with a no-observed-adverse-effect level of 1000 mg/kg in rats and dogs, showing no genotoxicity, cardiovascular, central, or respiratory toxicity...Several polymorphisms of each FABP gene have also been linked to pathological conditions, but it was unclear how several polymorphisms affected protein function. Overall, analysis of the literature to date suggests that pharmacological inhibition of FABPs in adults is of low risk."

Journal • Review • Cardiovascular • Oncology • FABP3 • FABP4 • FABP5 • FABP7

ART26.12, a novel fatty acid-binding protein 5 inhibitor, shows efficacy in multiple preclinical neuropathy models. (PubMed, Eur J Pain) - "This work now shows that ART26.12, a novel and selective inhibitor of FABP5, can prevent and treat multiple preclinical models of peripheral neuropathy. Given its excellent safety profile, further work is warranted to develop ART26.12 as a potential therapeutic tool for pain management."

Journal • Preclinical • Breast Cancer • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Musculoskeletal Pain • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor • FABP5

Artelo Biosciences Receives FDA Clearance of its IND Application for ART26.12, a Selective Fatty Acid Binding Protein 5 Inhibitor (GlobeNewswire) - "Phase 1 trial results expected in the first half of 2025...Artelo Biosciences, Inc...announced that the U.S. Food and Drug Administration (FDA) has issued a 'Study May Proceed' letter for the Company’s Investigational New Drug (IND) application for ART26.12, for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). FDA clearance of the ART26.12 IND application enables the Company to initiate its first-in-human Phase 1 single ascending dose study. Study startup activities have been initiated in collaboration with the internationally known contract research organization Worldwide Clinical Trials."

IND • P1 data • CNS Disorders • Pain • Peripheral Neuropathic Pain

Artelo Biosciences Announces Data Supporting Broad Potential Utility of its FABP Inhibitor Platform (GlobeNewswire) - "Targeting FABP5, a promising new approach to treat cancer, was featured in the presentation...Myles Osborn discussed novel preclinical data showing a direct anti-tumoral effect of oral treatment with ART26.12. These data are also supportive of Artelo’s planned development of ART26.12 in chemotherapy-induced peripheral neuropathy, where ART26.12 may be able to aid in treatment of the underlying cancer, in addition to the debilitating effects of painful neuropathies....'We expect to report on first-in-human trials with ART26.12 next year'."

Preclinical • Colon Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Artelo Biosciences Presents Preclinical Data on ART26.12 in Breast Cancer-Induced Bone Pain at the 34th Annual International Cannabinoid Research Society Symposium (GlobeNewswire) - "Artelo Biosciences...announced Professor Saoirse O’Sullivan, Vice President of Translational Sciences at Artelo, presented preclinical data related to ART26.12, Artelo’s novel fatty acid binding protein 5 (FABP5) inhibitor at the 34th Annual International Cannabinoid Research Society (ICRS) Symposium being held June 30 to July 5, 2024 in Salamanca, Spain...The presentation...highlights the effectiveness of ART26.12 in reducing pain behaviors induced by breast cancer in preclinical studies. This new data is from the fourth in a series of preclinical pain models that demonstrated similar activity with ART26.12. Specifically, effective doses and plasma exposures in the breast cancer bone pain study are consistent with previously published data of ART26.12 in oxaliplatin-induced peripheral neuropathy."

Preclinical • Breast Cancer • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor

Artelo Biosciences Announces Publication of New Peer-Reviewed Pre-Clinical Research Demonstrating ART26.12’s Effectiveness in Treating and Preventing Oxaliplatin-Induced Peripheral Neuropathy (EIN News) - "Artelo Biosciences, Inc...announced new research published in the peer-reviewed Journal of Pain....'In pre-clinical safety studies, ART26.12 has shown minimal off target effects, high oral bioavailability, and a NOAEL (no-observed-adverse-effect-level) of 1000 mg/kg/day administration'...The Company previously reported a positive pre-IND (investigational new drug) meeting with the Food and Drug Administration (FDA) and anticipates filing the IND for ART26.12 in the first half of 2024."

IND • Preclinical • Pain • Peripheral Neuropathic Pain

Discovery and preclinical evaluation of a novel inhibitor of FABP5, ART26.12, effective in Oxaliplatin-induced Peripheral Neuropathy. (PubMed, J Pain) - "PERSPECTIVE: Inhibition of fatty acid binding protein 5 (FABP5) is a novel target for reducing pain associated with chemotherapy. ART26.12 is a safe and well-tolerated small molecule FABP5 inhibitor effective at preventing and reducing pain induced with oxaliplatin through lipid modulation and activation of cannabinoid receptors."

Journal • Preclinical • Pain • Peripheral Neuropathic Pain • FABP4 • FABP5 • FABP7 • PPARA • TRPV1

Artelo Biosciences Announces Selection of Worldwide Clinical Trials as Clinical Research Organization to Support First-in-Human Study of ART26.12 (GlobeNewswire) - "Artelo Biosciences, Inc...today announced that it has selected Worldwide Clinical Trials...to support the Company’s planned Phase 1 trial with ART26.12, its Fatty Acid Binding Protein 5 (FABP5) inhibitor in development for the treatment of chemotherapy-induced peripheral neuropathy (CIPN)."

Licensing / partnership • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Artelo Biosciences to Present at the 13th Congress of the European Pain Federation on September 20th (GlobeNewswire) - "Artelo Biosciences, Inc...announced that Professor Saoirse O’Sullivan, Artelo’s Vice President of Translational Sciences, will be presenting at the 13th Congress of the European Pain Federation (EFIC) being held September 20-22, 2023 at the HUNGEXPO Exhibition Centre in Budapest, Hungary. Professor O’Sullivan’s presentation...is scheduled for 6:30 a.m. ET / 12:30 p.m. CEST on Wednesday, September 20, 2023."

Preclinical • CNS Disorders • Pain • Peripheral Neuropathic Pain

Artelo Biosciences Completes Positive Pre-IND Meeting with FDA for ART26.12 (GlobeNewswire) - "Artelo Biosciences, Inc...today announced it has completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the manufacturing, preclinical and clinical development plan for ART26.12. Based on the FDA’s feedback, the Company also announced that it plans to file an IND application for the use of ART26.12 in neuropathic pain in the first half of 2024."

FDA event • IND • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Artelo Biosciences to Present New Mechanism of Action Data on ART26.12 at the Gordon Research Conference on July 20, 2023 (GlobeNewswire) - "Artelo Biosciences, Inc...announced that Saoirse O’Sullivan, PhD, Vice President of Translational Sciences at Artelo Biosciences, will be presenting...at the Gordon Research Conference on 'Charting the Course to Novel Therapeutics From a Fundamental Understanding of Cannabinoid Neurobiology' being held July 16-21, 2023 at the Rey Don Jaime Grand Hotel in Spain....'We are particularly excited to share new information on the effects of our FABP inhibitor ART26.12 on not only cannabinoid receptors, but other receptors implicated in pain signaling, as well as lipidomic and transcriptome data that help us understand how ART26.12 elicits its effects in peripheral neuropathies'....The Company recently announced it expects pre-IND meeting feedback on its IND planning and development strategy from the Food and Drug Administration during the third quarter of this year with the goal of initiating clinical development in early 2024."

Clinical • FDA event • New trial • Immunology • Pain

Artelo Biosciences Announces Important New Data on ART26.12 Demonstrating Positive Effects in Multiple Models of Neuropathic Pain at the 33rd Annual International Cannabinoid Research Society Symposium (GlobeNewswire) - "Artelo Biosciences...announced that Professor Saoirse O’Sullivan, Vice President of Translational Sciences at Artelo, presented preclinical data related to ART26.12, Artelo’s novel fatty acid binding protein 5 (FABP5) inhibitor at the 33rd International Cannabinoid Research Society (ICRS) Symposium in Toronto, Ontario, Canada....There are very limited therapeutic options currently available and these existing treatments are often associated with a significant and undesirable side effect profile...'We are making substantial progress in advancing this important program towards the clinic and are looking forward to receiving pre-IND meeting minutes from the FDA during the third quarter of this year, which will mark a substantial milestone for ART26.12.'"

FDA event • Preclinical • CNS Disorders • Pain

Artelo Biosciences Selected for Oral Presentation at the 32nd Annual ICRS Symposium in Galway, Ireland (GlobeNewswire) - "Dr. Sullivan will be presenting pre-clinical data related to ART26.12, the Company’s lead fatty acid binding protein 5 (FABP5) inhibitor. The Company plans to provide a summary of the research following the presentation. The ICRS Symposium is being held at the Bailey Allen Hall at the National University of Ireland, Galway, from June 25-30, 2022."

Preclinical • Oncology • Pain

Artelo Expands Collaboration with Trinity College Dublin to Investigate Cellular Biology of Fatty Acid Binding Protein (FABP) Inhibition In Cancer (GlobeNewswire) - "Artelo Biosciences, Inc...announced that the Company has entered into a second collaboration with Richard K. Porter, Ph.D., of the School of Biochemistry & Immunology at Trinity College Dublin, Ireland....Professor Porter’s focus will be on investigating the molecular basis of fatty acid binding protein (FABP) inhibition in cancer and the potential of the ART26.12 platform for the treatment of various tumors."

Licensing / partnership • Oncology

Artelo Biosciences Reports Third Quarter Fiscal 2021 Financial Results and Provides Business Update (GlobeNewswire) - "ART12.11 is a patented cocrystal of cannabidiol (CBD) and tetramethylpyrazine (TMP), which may have the potential to prevent cancer cell growth and kill cancer cells. The Company also continues to generate data on its FABP5 inhibitor, ART26.12, as a potential anti-cancer treatment, supported by FABP5's emerging utility as a biomarker...Presented a poster at ICRS related to Artelo’s ART12.11 CBD Cocrystal and the potential to prevent cancer cell growth and kill cancer cells through co-administration of CBD and TMP."

Clinical • Preclinical • Oncology

Artelo Biosciences Accepted into the Alderley Park Oncology Development Program for FABP5 Inhibitor Biomarker Development (GlobeNewswire) - "Artelo Biosciences, Inc...today announced that it has been accepted into the first round of the Alderley Park Oncology Development Program, a UK national program designed to offer advice, guidance, and financial support to develop and progress innovative oncology projects...the detection of elevated FABP5 associated with other tumor types is suggesting the target for ART26.12 may be more broadly relevant..."

Clinical • Oncology

Artelo Biosciences Reports Second Quarter Fiscal Year 2020 Financial Results and Provides Business Update (GlobeNewswire, Artelo Biosciences) - "For our lead clinical program ART27.13, manufacturing and regulatory approvals are proceeding as planned for the initiation of our Phase 1b/2a clinical study for the treatment of cancer-related anorexia. In addition, we reinforced our intellectual property position for ART12.11 and are closing in on the identification of the lead candidate for ART26.12, our fatty acid binding protein 5 (FABP5) inhibitor program for the potential treatment of various cancers, pain and inflammation. 'Despite the impact of the COVID-19 pandemic, Artelo remains well positioned to achieve a number of meaningful milestones in 2020, including initiating enrollment in our Phase 1b/2a clinical study of ART27.13, reporting key pre-clinical data related to ART12.11 and ART26.12, as well as advancing discussions with potential development partners,' added Mr."

Commercial • Enrollment status • New trial • Preclinical • Anorexia • CNS Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Novel Coronavirus Disease • Oncology • Pain • Psychiatry

Newly added product (GlobeNewswire) - Preclinical, Oncology

Pipeline update