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Artelo Biosciences, Inc. (NASDAQ: ARTL) is a clinical-stage biopharmaceutical company headquartered in San Diego, California, with an additional office in Dublin, Ireland. The company is dedicated to the development and commercialization of proprietary therapeutics that modulate lipid signaling pathways, including the endocannabinoid system. Artelo leverages past research and cutting-edge science to accelerate the development of a diverse portfolio of novel therapeutics with the potential to dramatically improve patient care in major markets.
Core to Artelo's mission is their focus on discovering, licensing, developing, and commercializing treatments that control endocannabinoid systems. This includes cannabinoid-based therapies, both derived from the cannabis plant and synthetic cannabinoids, as well as new chemical entities and compounds. The company's flagship program is a patent-protected cannabinoid drug combination treatment aimed at rare and orphan diseases.
One of their notable projects, ART12.11, has demonstrated improved bioavailability of CBD in both fed and fasted states compared to CBD alone. This proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP) offers biopharmaceutic advantages over standard CBD compositions, showing better pharmacokinetics and improved efficacy in preclinical studies. The US-issued composition of matter patent for ART12.11 is enforceable until December 10, 2038.
Another significant program is ART26.12, a Fatty Acid Binding Protein 5 (FABP5) inhibitor being developed as a non-opioid, non-steroidal analgesic for chemotherapy-induced peripheral neuropathy (CIPN) and potentially other neuropathic pains. ART26.12 has shown promising results in preclinical studies, reducing pain in models of diabetic neuropathy and chemotherapy-induced peripheral neuropathy.
Artelo is also advancing ART27.13, a G-Protein Coupled Receptor (GPCR) agonist targeting CB1 and CB2 receptors. This program is currently in the Cancer Appetite Recovery Study (CAReS) Phase 2a trial, aimed at improving body weight, appetite, muscle degeneration, and quality of life in cancer patients. The company has reported positive progress in clinical trials and aims to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, pain, neuropathy, and inflammation.
Led by experienced biopharmaceutical executives and backed by collaborations with highly respected researchers and technology experts, Artelo applies rigorous scientific, regulatory, and commercial discipline to develop high-impact therapies. The company maintains a strong presence in global biopharma innovation hubs, ensuring close access to world-class research expertise.
Artelo Biosciences (Nasdaq: ARTL) reported its Q2 2024 financial results and provided a business update. The company is entering a productive phase in clinical development, with multiple readouts expected over the next 18 months. Key highlights include:
- FDA clearance to initiate clinical trials for ART26.12 for chemotherapy-induced peripheral neuropathy
- Anticipated full enrollment in Phase 2a of the CAReS trial for ART27.13 by early 2025
- ART12.11 in final stages of product formulation, potential clinical study entry in early 2025
Financially, Artelo reported $5.6 million in cash and cash equivalents as of June 30, 2024, with an additional $1.3 million received from UK R&D tax credits in July. Q2 2024 net loss was $2.4 million, or $0.75 per share, compared to $1.6 million, or $0.56 per share, in Q2 2023.
Artelo Biosciences (Nasdaq: ARTL) has received FDA clearance for its Investigational New Drug (IND) application for ART26.12, a selective Fatty Acid Binding Protein 5 (FABP5) inhibitor. This clearance allows Artelo to initiate a Phase 1 single ascending dose study for chemotherapy-induced peripheral neuropathy (CIPN), a condition with no FDA-approved treatment. ART26.12 is being developed as a non-opioid approach to manage painful neuropathies. The company expects Phase 1 trial results in the first half of 2025. Artelo's FABP inhibitor platform has attracted interest from potential partners due to its preclinical efficacy, novel mechanism, and strong patent estate.
Artelo Biosciences presented comparative preclinical data on ART12.11 at the 34th Annual International Cannabinoid Research Society Symposium. Findings revealed ART12.11, a novel cannabidiol: tetramethylpyrazine cocrystal, has a unique pharmacokinetic profile, potentially superior to existing treatments for anxiety-related disorders. Research showed ART12.11 increased plasma levels of CBD in rodents and displayed efficacy in reducing anxiety and depressive symptoms. The drug demonstrated similar plasma levels of CBD as Epidiolex, suggesting its potential as an effective treatment. Artelo is currently optimizing ART12.11's oral delivery formulation.
Artelo Biosciences (Nasdaq: ARTL) announced promising data from several research studies on its Fatty Acid Binding Protein 5 (FABP5) inhibitors at the ICRS Symposium, held June 30 – July 5, 2024, in Salamanca, Spain. The studies demonstrated the potential of FABP5 inhibitors in treating cancer, psoriasis, and anxiety disorders. ART26.12, one of Artelo’s lead inhibitors, showed anti-tumor effects in colon cancer models and potential for treating chemotherapy-induced peripheral neuropathy and psoriasis. Another inhibitor, SBFI103, improved depressive-like behaviors in preclinical studies. These findings support further development of FABP5 inhibitors, with first-in-human trials expected next year.
Artelo Biosciences (Nasdaq: ARTL) presented preclinical data on ART26.12, a fatty acid-binding protein 5 (FABP5) inhibitor, at the 34th Annual International Cannabinoid Research Society Symposium. The data demonstrated ART26.12's effectiveness in reducing pain behaviors caused by breast cancer in preclinical studies. This study is the fourth in a series showing consistent efficacy in various pain models, including oxaliplatin-induced peripheral neuropathy. Artelo aims to initiate human trials following FDA approval of their Investigational New Drug application. Breast cancer often leads to bone metastasis, causing severe pain. ART26.12 offers a novel, non-opioid, non-steroidal treatment option for such pain.
Artelo Biosciences (Nasdaq: ARTL), a clinical-stage pharmaceutical company, presented new preclinical data on ART26.12 at the 57th Annual Scientific Meeting of the British Pain Society. The conference took place from June 4-6, 2024, in Nottingham, UK. ART26.12, a Fatty Acid Binding Protein 5 (FABP5) inhibitor, showed efficacy in reducing breast cancer-induced bone pain and diabetic neuropathy in preclinical models. Effective doses and plasma exposures were consistent with previous data. Artelo plans to submit an Investigational New Drug application to the U.S. FDA this month. This non-opioid, non-steroidal treatment is seen as a promising alternative for pain management.
Artelo Biosciences (Nasdaq: ARTL) presented new pre-clinical data on ART12.11 at the CT-CANN24 conference, demonstrating that ART12.11, a patented cocrystal of CBD and TMP, has comparable pharmacokinetics to Epidiolex in rats. Epidiolex, an FDA-approved oral CBD solution, saw over $845 million in net sales in 2023. ART12.11, in an unoptimized formulation, showed similar CBD levels in plasma to Epidiolex, suggesting potential for a solid dosage form that is preferred for adolescents and adults due to better dosing precision, storage, and transport. Previous animal studies indicated ART12.11 outperformed CBD in stress-induced anxiety and depression with a lower CBD amount. Artelo is developing an optimized tablet form of ART12.11 for clinical studies, aiming to broaden CBD research in larger populations.
Artelo Biosciences, Inc. (Nasdaq: ARTL) reported financial results for Q1 2024, highlighting progress in developing treatments for cancer, pain, dermatologic, and neurological conditions. The company's lead inhibitor, ART26.12, shows promise in treating neuropathic pain. Artelo's cash and investments stood at $7.6 million, with R&D expenses at $1.5 million and a net loss of $2.5 million.
Artelo Biosciences, Inc. (Nasdaq: ARTL) will be presenting at the 2024 Pharma Partnering Summit on May 14th, with CEO Gregory D. Gorgas discussing the company's focus on developing treatments for cancer, pain, dermatologic, and neurological conditions. The summit provides networking and partnership opportunities in the life sciences sector.