FABP7

SOLANA BEACH, Calif., Aug. 13, 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 reported its financial and operating results for the three months ended June 30, 2024 and provided a business update. “Artelo is entering an unprecedented phase of productivity in clinical development,” commented Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “Specifically, we look forward to multiple clinical readouts over the next 18 months across our portfolio. Most recently, we received clearance from the U.S. Food and Drug Administration (FDA) to initiate clinical trials for ART26.12 for the treatment of chemotherapy-induced peripheral neuropathy and Phase 1 trial results are expected during the first half of 2025. In addition, we anticipate full enrollment in the Phase 2a portion of the CAReS trial with our lead clinical asset, ART27.13, for the treatment of cancer-related anorexia near the end of 2024 or early 2025. To date, there have been no serious adverse events reported related to the study drug in CAReS. Finally, ART12.11, our proprietary cocrystal of CBD and TMP intended for the treatment of anxiety and depression, is in the final stages of product formulation as an oral solid, creating the potential to enter a clinical study early next year.” “With over $5.6 million of cash and cash equivalents as of June 30, 2024, and the receipt of approximately $1.3 million in cash from the UK government from R&D tax credits on July 10, 2024, we have the momentum to meaningfully advance our asset portfolio over the coming months,” concluded Mr. Gorgas. Other Company Highlights: Presented data from multiple preclinical studies at the 34th Annual International Cannabinoid Research Society Symposium Efficacy of ART26.12 in Breast Cancer-Induced Bone PainResults supporting broad potential utility of FABP Inhibitor platformMultiple studies confirming ART12.11’s potential advantages as a product candidate for the treatment of anxiety related disorders Presented highly encouraging data towards developing a solid dosage form of ART12.11, including comparative data to the Epidiolex formulation of CBD. Epidiolex had annual sales in excess of $700 million in 2023Announced publication of peer-reviewed article highlighting FABP7 as a promising novel target in cancer therapy Financial Results for Quarter Ended June 30, 2024 Cash and Investments: Cash and investments totaled $5.6 million as of June 30, 2024.R&D Expenses: Research and development expenses were $1.7 million for the three months ended June 30, 2024, compared to $0.8 million for the same period in 2023.G&A Expenses: General and administrative expenses were $0.8 million for the three months ended June 30, 2024, compared to $1.0 million for the same period in 2023.Net Loss: For the three months ended June 30, 2024, net loss was $2.4 million, or $0.75 per basic and diluted common share, which included $0.1 million of non-cash expenses, compared to a net loss of $1.6 million, or $0.56 per basic and diluted common share for the three months ended June 30, 2023, which included $0.2 million of non-cash expenses.R&D Tax Credit: Subsequent to the end of the quarter, the Company received approximately $1.3 million in cash on July 10, 2024, from the UK government related to qualified prior research and development expenses. About ART27.13ART27.13 is a G-Protein Coupled Receptor (GPCR) agonist, a highly potent, peripherally restricted new chemical entity, targeting CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Originally developed by AstraZeneca plc, ART27.13 has been in clinical studies with over 250 subjects. A statistically significant and dose-dependent increase in body weight was observed in patients with back pain who were otherwise healthy. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Having completed a Phase 1 study in cancer patients where ART27.13 demonstrated an excellent safety profile, Artelo is now advancing it in the CAReS trial as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Currently, there is no FDA-approved treatment for cancer anorexia cachexia syndrome. About CAReSThe Cancer Appetite Recovery Study (CAReS) is a Phase 1b/2a randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in patients with cancer anorexia and weight loss. Cancer-related anorexia, or the lack or loss of appetite in the person with cancer, may result from the cancer and/or its treatment with radiation or chemotherapy. It is common for people with cancer to lose weight. Anorexia and the resulting weight loss can affect a patient’s health, often weakening their immune system and causing discomfort and dehydration. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to chemotherapy. Now completed, the Phase 1b portion of the CAReS study was designed to determine the most effective and safest dose of ART27.13 for dosing in the Phase 2a stage. Currently enrolling, the Phase 2a portion of the CAReS study is designed to determine estimates of activity of ART27.13 in terms of lean body mass, weight gain, and improvement of anorexia. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817) About ART26.12Fatty 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 cleared by FDA to initiate first-in-human studies, is a potent and selective inhibitor of FABP5 being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic, with an initial clinical study 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. About ART12.11ART12.11 is Artelo’s wholly owned, proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). Isolated as a single crystalline form, ART12.11 has exhibited better pharmacokinetics and improved efficacy compared to other forms of CBD in nonclinical studies. Superior pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability profile may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The US-issued composition of matter patent for ART12.11 is enforceable until December 10, 2038. 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, LLCTel: 212-671-1020Email: ARTL@crescendo-ir.com

SOLANA BEACH, Calif., April 23, 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, dermatological, and neurological conditions, today announced the publication of an article, “The emerging role of fatty acid binding protein 7 (FABP7) in cancers,” in Drug Discovery Today, a peer-reviewed journal. The article analyzes the results of various studies and presents a comprehensive analysis of FABP7’s role in a variety of cancers and its correlation with patient prognosis, as well as its potential utility as a validated target in cancer treatment. The publication reveals that FABP7, an intracellular protein involved in the uptake, transportation, metabolism, and storage of fatty acids, is upregulated in several cancers including breast, brain, and kidney cancers and is generally associated with a poor patient prognosis. Additionally, the evidence shows that both genetic and pharmacological inhibition of FABP7 led to reduced tumor cell growth, migration, and invasion in multiple studies. Moreover, inhibition of FABP7 improved host survival rates, particularly in brain cancers, indicating its role as a novel target in cancer. “Artelo is dedicated to furthering research on FABP inhibition including selective- and pan-FABP inhibition, with the aim of providing new therapeutic options for patients battling cancer and other serious conditions,” said Professor Saoirse Elizabeth O’Sullivan, Vice President of Translational Sciences at Artelo Biosciences. “The insights highlighted in this review continue to underscore the potential impact of our FABP inhibitor platform in several therapeutic areas.” Artelo is currently evaluating multiple compounds for their therapeutic potential from the Company’s extensive FABP inhibitor library. The most advanced of these is ART26.12, a novel, potent and selective inhibitor of FABP5. In preclinical studies, ART26.12 demonstrated positive results in cancer, cancer bone pain, and painful neuropathies such as chemotherapy-induced peripheral neuropathy (CIPN). Artelo plans to investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) during the second quarter of 2024 for the development of ART26.12 in CIPN. Approximately 40% of cancer patients treated with certain chemotherapies will develop neuropathic pain which often requires dose reduction or cessation of anti-cancer treatment and there is currently no FDA-approved therapy to treat or prevent CIPN. For more information about Artelo Biosciences and our commitment to innovative therapies, please visit our website at About ART26.12 ART26.12, Artelo’s lead Fatty Acid Binding Protein (FABP) inhibitor, is a potent and selective inhibitor of FABP5 being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic, with an initial clinical study planned for chemotherapy-induced peripheral neuropathy (CIPN). 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. Beyond ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs have shown therapeutic promise for the treatment of certain cancers, cancer bone pain, neuropathic and nociceptive pain, dermatological and anxiety disorders. 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, 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 on X (formerly 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, market opportunity, competitive position, 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 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

胆固醇是调控膜功能的重要脂类分子，作为高度疏水的小分子，胆固醇如何在细胞内精准运输是长期未回答的重要科学问题。2024年3月1日，细胞生物学领域著名期刊Journal of Cell Biology刊发了武汉大学生命科学学院、高等研究院、泰康生命医学中心宋保亮院士、罗婕教授和殷雷教授合作的最新研究论文，题为“Fatty acid-binding proteins 3, 7, and 8 bind cholesterol and facilitate its egress from lysosomes《脂肪酸结合蛋白3, 7, 8结合胆固醇并协助胆固醇运出溶酶体》”。该工作揭示了脂肪酸结合蛋白家族是一类新的甾醇转运蛋白，解析了FABP7介导低密度脂蛋白来源的胆固醇在细胞内运输的分子与结构机制，证明了同家族成员FABP3和FABP8也参与胆固醇从溶酶体的输出，并能在体外转运胆固醇类似物。FABP7是从宋保亮院士团队前期在“溶酶体—过氧化物酶体膜接触介导胆固醇运输”（Chu et al., Cell 2015）的研究中发现的。它对n-3和n-9多不饱和脂肪酸具有高亲和力，并且能够促进二十二碳六烯酸、二十碳五烯酸和油酸的转运。FABP7及其家族成员FABP3和FABP8能结合并转运胆固醇属首次报道。FABP7缺陷会导致低密度脂蛋白来源的胆固醇在溶酶体中大量堆积，并降低质膜胆固醇水平（图1）。图1. FABP7缺陷阻碍胆固醇从溶酶体向质膜运输结构分析显示，FABP7具有一个疏水性口袋，能将胆固醇包裹于其中（图2），帮助其在胞质水相中运输。体外结合实验表明，胆固醇与油酸等脂肪酸能竞争性结合FABP7；体外运输实验证明FABP3，7和8能在人工脂质体之间有效地转运胆固醇类似物脱氢麦角固醇。图2. FABP7结合胆固醇的晶体结构解析该工作是宋保亮院士团队继发现溶酶体—过氧化物酶体—内质网膜接触这一全新胆固醇运输途径（Chu et al., Cell 2015; Xiao et al., Sci China Life Sci 2019; 分别入选“2015年中国生命科学十大进展”与“第八届中国科协优秀科技论文”）之后的又一重要进展。武汉大学高等研究院的博士生方贤秀和生命科学学院博士生魏鹏程为本论文共同第一作者，宋保亮教授、殷雷教授和罗婕教授为共同通讯作者。该研究的其它作者还包括武汉大学生科院博士生赵凯和盛召辰。该研究工作得到了基金委创新群体、基金委重大研究计划、湖北省自然科学基金的资助。论文链接：https://rupress.org/jcb/article/223/4/e202211062/276590/原文链接：https://bio.whu.edu.cn/info/1465/96926.htm本文仅用于学术分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！