ART27.13 / Artelo Biosci, adMare BioInnovations, AstraZeneca - LARVOL DELTA

Cachexia and Wasting in Chronic Illness: Regulatory and Clinical Trial Update. (PubMed, J Cachexia Sarcopenia Muscle) - "In contrast, TCMCB07, an MC-4 receptor antagonist, demonstrated promising results in preclinical and early-phase human studies, showing weight stabilization and improved caloric intake with good tolerability. ART27.13, a dual CB1/CB2 receptor agonist, also demonstrated positive effects in appetite stimulation and weight stabilization. For S-pindolol, which targets appetite and metabolism, Phase IIb/III trials are to be initiated, following an earlier Phase II trial that showed improved muscle mass and muscle strength (hand grip strength). Future treatments must focus on integrating patient-centred goals, therapeutic mechanisms and meaningful clinical outcomes."

Journal • Review • Cachexia • Oncology

Advancements of investigational agents for cancer cachexia: what clinical progress have we seen in the last 5 years? (PubMed, Expert Opin Investig Drugs) - "This review covers key investigational therapies developed over the past five years, with a focus on agents targeting Growth Differentiation Factor 15 (GDF-15), including ponsegromab, AV-380, and NGM120. Additional agents include ghrelin receptor agonists (e.g. anamorelin), anabolic/catabolic modulators (ACM-001), and cannabinoids (ART27.13). The evolving role of low-dose olanzapine is also discussed in the 2023 ASCO guideline update...The lack of standardized endpoints, heterogeneity of the syndrome, and absence of FDA-approved treatments remain major barriers to treatment implementation. Multimodal strategies combining pharmacological treatment with nutritional and rehabilitative support are likely to define future therapeutic success."

Journal • Cachexia • Oncology • GDF15

Ptdp-1170, a peripherally restricted cannabinoid receptor agonist, attenuated oral cancer-induced nociception without catatonic effects (Neuroscience 2025) - "We synthesized PTDP-1170 and compared it with two reference PRCBs agonists, AZD1940 and PrNMI, which were obtained from a commercial vendor...Our newly synthesized PTDP-1170 nearly abolished cancer supernatant-induced nociception in the tongue [97.18% pain reduction at 2 hours after treatment, 1.29 ± 0.15 versus 1.25 ± 0.09] without eliciting central catatonic effects. PTDP-1170, a peripherally restricted cannabinoid receptor agonist, provides superior cancer pain relief than the existing PRCBs while avoiding central effects, making it a promising therapeutic candidate for treating oral cancer pain."

CNS Disorders • Pain

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

Cancer-Cachexia-Induced Human Skeletal Muscle Myotube Degeneration Is Prevented via Cannabinoid Receptor 2 Agonism In Vitro. (PubMed, Pharmaceuticals (Basel)) - "Furthermore, the addition of the CBR antagonist AM630, but not the CBR antagonist Rimonabant, abolished the protective effect of ART27.13. In short, we have established a convenient and robust in vitro model of cancer-induced human skeletal muscle cachexia. The data obtained using the model demonstrate the therapeutic potential of ART27.13 in cancer-induced cachexia prevention and provides evidence indicating that this effect is via CBR, and not CBR."

Journal • Preclinical • Cachexia • Colon Cancer • Colorectal Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Artelo Biosciences Announces Publication of New Peer-Reviewed Research Demonstrating Protective Properties of ART27.13 Against Muscle Degeneration Caused by Certain Cancers (GlobeNewswire) - "Artelo Biosciences, Inc...today announced new research published in the peer-reviewed journal Pharmaceuticals. The research article...highlights the promising protective properties of the Company’s clinical asset, ART27.13, in helping prevent muscle degeneration caused by cancer...Not only did the research show that ART27.13 protects against muscle wasting in the in vitro model, but also shows that the activity was mediated by the CB2 receptor....'We are actively enrolling patients in the trial and look forward to reporting on our continued progress.'" "

Enrollment status • Preclinical • Anorexia • Cachexia • Oncology

Artelo Biosciences Initiates the Phase 2a Portion of its CAReS Trial EvaluatingART27.13 for the Treatment of Cancer-Related Anorexia and Weight Loss (GlobeNewswire) - "Artelo Biosciences, Inc...announced it has initiated the Phase 2a portion of its Cancer Appetite Recovery Study (CAReS), evaluating ART27.13 for the treatment of cancer-related anorexia and weight loss....'By tripling the number of treatment centers and broadening patient eligibility criteria to include concurrent anti-cancer therapies, our goal is to complete Phase 2a patient enrollment by mid-2024'."

Trial status • Anorexia • Oncology

Artelo Biosciences Completes Enrollment of the First Three Cohorts in its CAReS Study Evaluating ART27.13 for the Treatment of Cancer-Related Anorexia and Weight Loss (GlobeNewswire) - P1b/2a | N=49 | CAReS (2020-000464-27) | Artelo Biosciences Limited | "Artelo Biosciences, Inc...announced the completion of enrollment of the first three cohorts in the Cancer Appetite Recovery Study (CAReS) and the initiation of a fourth cohort expected to complete the first stage of the Phase 1b clinical trial of ART27.13...'The CAReS safety review committee has reviewed the data thus far and has concluded that ART27.13 has been well-tolerated with no serious adverse events attributable to the investigational drug in patients suffering from anorexia associated with cancer'....The mild to moderate adverse events observed in CAReS that have been attributed to ART27.13 required no dose reductions or terminations and many of the adverse events required no medical intervention at all."

Enrollment closed • P1 data • Cachexia • Oncology

Artelo Biosciences Reports Positive Pre-clinical Results for Lead Program in Cancer-Related Cachexia (GlobeNewswire) - "Artelo Biosciences, Inc...announced that ART27.13, a peripherally selective G-Protein Coupled Receptor (GPCR) full agonist currently in clinical development for cancer-related anorexia, shows promising pre-clinical results in protecting human muscle cells from cancer-induced muscle degeneration (cachexia) via a CB2 mediated mechanism of action....'we have evidence that ART27.13 targets a second mechanism of action, the cannabinoid receptor CB2, with these positive pre-clinical results.'"

Preclinical • Anorexia • Oncology

Cannabis and orofacial pain: a systematic review. (PubMed, Br J Oral Maxillofac Surg) - "Conversely, two orally-administered synthetic cannabinoid receptor agonists (AZD1940 and GW842166) failed to demonstrate significant analgesic effects following surgical third molar removal. Further research is warranted to explore and substantiate the therapeutic role of CBPMs in the context of orofacial pain and inflammation. As evidence supporting their use expands, healthcare professionals should pay close attention to outcomes and changes to legislation that may impact and potentially benefit their patients."

Journal • Review • Immunology • Inflammation • Musculoskeletal Pain • Neuralgia • Pain

"$ARTL Artelo Anticipates Accelerated Clinical Development for ART27.13 Following Its Classification Change in the United Kingdom https://t.co/DcYtp7F9nL" (@stock_titan)

Clinical

A Phase 1/2 clinical trial of ART27.13 in patients with a lack or loss of appetite and weight loss due to having cancer. (clinicaltrialsregister.eu) - P1/2; N=49; Ongoing; Sponsor: Artelo Biosciences Limited

Clinical • New P1/2 trial • Anorexia • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • 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