作者: van der Horst, Cas ; de Koning, Elisa J M ; Bouma, Jara ; Grether, Uwe ; Wittwer, Matthias B ; Kumar, Sanjay Sunil ; van den Berg, Barry J W ; van der Stelt, Mario ; Guba, Wolfgang ; Rufer, Arne C ; Heitman, Laura H ; Hoare, Samuel R J

Studying biased signaling of G protein-coupled receptors (GPCRs) holds promise for the identification of ligands with a better therapeutic window. However, proper examination of biased signaling remains challenging by risking introduction of system or observation bias. Therefore, we developed a novel multiplex assay that simultaneously and kinetically detects cAMP production and ß-arrestin-2 recruitment in the same well. To investigate the applicability of the kinetic multiplex assay, we profiled seventeen clinically tested agonists for the cannabinoid CB₂ receptor (CB₂R), a promising GPCR for treating tissue injury and inflammation. Agonist-mediated CB₂R activation and signaling was time sensitive, dependent on the agonist. Similar potency and efficacy parameters were obtained from semi-kinetic and kinetic analysis, while the latter provided additional signaling rate constants for signaling onset (k₁) and decline (k₂). Fast CB₂R engagement (k_on) of agonists resulted in increased affinity and potency. Slow dissociation of agonists extended the interaction between CB₂R and ß-arrestin-2. Moreover, superagonists Tedalinab, Olorinab, PRS-211375 and ART-27.13 were characterized by fast k₁ values. No significant biased signaling was observed for the investigated CB₂R agonists. To validate the assay, the reported biased compound JWH145 was tested in a multiplex assay developed for CB₁R and confirmed that our new method is able to detect bias. Altogether, this study accentuates the potential of multiplexing functional responses and performing kinetic analyses to provide an extensive preclinical profile for agonists that may better predict their in vivo pharmacological effects. Ultimately, providing full kinetic context for binding and signaling of GPCR agonists could advance drug discovery efforts.

2025-12-01·Journal of Cachexia Sarcopenia and Muscle

Cachexia and Wasting in Chronic Illness: Regulatory and Clinical Trial Update

Article

作者: Laird, Barry J. A. ; Anker, Stefan D. ; Skipworth, Richard J. E. ; Fioretti, Francesco ; von Haehling, Stephan ; Del Fabbro, Egidio ; Coats, Andrew J. S. ; Butler, Javed

ABSTRACT:

Cachexia, a syndrome marked by nonintentional weight loss, muscle wasting, functional decline and poor prognosis, affects 50%–80% of cancer patients, severely impacting quality of life, treatment tolerance and survival. A ‘Regulatory and Trial Update Workshop’ was organized by the Society on Cachexia and Wasting Disorders (SCWD) in December 2024 in Washington, DC, focused on clinical trial endpoints, standards of care and recent advancements. This article provides a summary of the discussions that were held during the first day of the workshop. Despite ongoing research, effective therapies for cachexia remain limited. Existing treatments, such as nutritional supplements, progestins, anti‐inflammatories and anabolic agents, have shown mixed results, often improving appetite or lean mass without consistent functional benefits. Common muscle mass measurements, like CT scans of the L3 vertebra, are inadequate as primary endpoints because of biological variability and small effect sizes and because they do not necessarily translate into clinical benefit. Trials continue to face challenges in meeting regulatory requirements, which mandate improvements in both body composition and functional outcomes. Regulatory consensus emphasizes demonstrating clinically meaningful benefits in patient‐reported outcomes/physical function and/or morbidity–mortality using validated instruments, adequate safety exposure, recognition that handgrip and weight alone are insufficient, feasibility in advanced disease, consideration of general activity measures, optional but informative body composition data and, for a pan‐cancer label, benefits across at least three distinct cancers. Patient‐centred endpoints, emphasizing real‐life functioning and social participation, are essential as patients prioritize daily activity and independence over isolated physical measures. Clinical trials presented during the meeting included the MENAC trial, which tested a multimodal intervention combining nutrition, exercise, anti‐inflammatory drugs and cancer therapy, achieved modest weight stabilization but no significant improvements in muscle mass or activity. 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.

Pharmaceuticals (Basel, Switzerland)

Cancer-Cachexia-Induced Human Skeletal Muscle Myotube Degeneration Is Prevented via Cannabinoid Receptor 2 Agonism In Vitro

Article

作者: Yates, Andrew ; Noone, John ; Porter, Richard K. ; O’Sullivan, Saoirse E. ; Karavyraki, Marilena ; Rooney, Mary F.

Cachexia syndrome, leading to reduced skeletal muscle and fat mass, is highly prevalent in cancer patients, resulting in further negative implications for these patients. To date, there is no approved therapy for cachexia syndrome. The objective of this study was to establish an in vitro model of cancer cachexia in mature human skeletal muscle myotubes, with the intention of exploiting the cell model to assess potential cachexia therapeutics, specifically cannabinoid related drugs. Having cultured and differentiated primary human muscle myoblasts to mature myotubes, we successfully established two cancer cachexia models using conditioned media (CM) from human colon adenocarcinoma (SW480) and from non-small-cell lung carcinoma (H1299) cultured cells. The cancer-CM-induced extensive myotube degeneration, demonstrated by a significant reduction in mature myotube diameter, which progressed over the period studied. Myotube degeneration is a characteristic feature of cancer cachexia and was used in this study as an index of cachexia. Expression of cannabinoid 1 and 2 receptors (CB1R and CB2R) was confirmed in the mature human skeletal muscle myotubes. Subsequently, the effect of cannabinoid compounds on this myotube degeneration were assessed. Tetrahydrocannabinol (THC), a partial CB1R/CB2R agonist, and JWH133, a selective CB2R agonist, proved efficacious in protecting mature human myotubes from the deleterious effects of both (SW480 and H1299) cancer cachexia conditions. ART27.13, a full, peripherally selective CB1R/CB2R agonist, currently being trialled in cancer cachexia (IRAS ID 278450, REC 20/NE/0198), was also significantly protective against myotube degeneration in both (SW480 and H1299) cancer cachexia conditions. Furthermore, the addition of the CB2R antagonist AM630, but not the CB1R 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 CB2R, and not CB1R.

项与 ART27.13 相关的新闻（医药）

2026-02-24

·BioSpace

Artelo Biosciences Provides Business Update Highlighting Clinical Progress and Reports Fiscal 2025 Year-End Financial Results

Positive human data and upcoming clinical catalysts across portfolio SOLANA BEACH, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), 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 provided a business update and announced its financial and operational results for the fiscal year ended December 31, 2025. Business Highlights: Successful Phase 1 study with ART26.12: Reported positive first-in-human Phase 1 single ascending dose (SAD) clinical data demonstrating a favorable safety profile, predictable pharmacokinetics, and dosing flexibility. As a result, the Company is working to complete preparations to open enrollment to the multiple ascending dose (MAD) study in the third quarter of 2026. Positive interim Phase 2 results with ART27.13: Announced positive interim Phase 2 CAReS data demonstrating improvements in body weight, lean body mass, and physical activity alongside a favorable side-effect pro to placebo in patients with cancer anorexia-cachexia syndrome. Streamlined regulatory pathway for ART12.11: Received favorable UK MHRA regulatory guidance supporting Phase 1 study plans and potential accelerated pathways. Pending outcome of toxicology study results in 2026, the Company plans to initiate human clinical studies with an oral solid dosage form during the first half of 2027. “2025 was a pivotal year clinically for Artelo, marked by meaningful progress across all our core programs,” stated Gregory D. Gorgas, Chief Executive Officer of Artelo, “We successfully completed a first-in-human Phase 1 SAD study for ART26.12 and validated our FABP5 inhibition approach to pain management. These results were further strengthened by positive preclinical efficacy data with ART26.12 which demonstrated sustained analgesic effects without tolerance in an osteoarthritis pain model, with efficacy comparable to naproxen and a potentially safer profile. We are excited to be progressing this program as a differentiated, non-opioid, non-steroidal alternative for pain” “We were very pleased to report positive interim Phase 2 CAReS data for ART27.13. These results reinforced ART27.13’s potential as a meaningful therapeutic strategy to address the significant unmet medical need in patients with cancer anorexia-cachexia syndrome. In addition, we received a Notice of Allowance from the European Patent Office covering the intended commercial formulation of ART27.13 and extending patent protection through December 2041. Together, the clinical progress and enhanced intellectual property position have advanced partner interest in supporting the program’s next stage of development.” “In parallel, we were pleased with the UK MHRA’s favorable regulatory guidance supporting our Phase 1 clinical plans for ART 12.11. As presented at the 35th Annual International Cannabinoid Research Society Symposium, ART12.11’s positive preclinical efficacy was confirmed by its robust antidepressant-like activity in a stress-induced depression model, with efficacy comparable to sertraline (Zoloft) and differentiated cognitive benefits not observed with leading SSRIs. Our team is therefore preparing to initiate first-in-human studies with an oral solid dosage form early next year.” Gorgas concluded by stating that “Looking ahead, we are firmly focused on disciplined clinical execution, strategic collaboration, and prudent capital management to drive shareholder value.” Fiscal 2025 Year-End Financial Results R&D Expenses: Research and development expenses were $5.4 million for the year ended December 31, 2025, compared to $6.0 million for the year ended December 31, 2024. G&A Expenses: General and administrative expenses were $6.0 million for the year ended December 31, 2025, compared to $4.1 million in the prior year. Net Loss: For the year ended December 31, 2025, net loss was 12.9 million, or $12.52 per basic and diluted common share, compared to a net loss of $9.8 million for the year ended December 31, 2024. Cash and Investments: Cash and investments totaled $0.6 million as of December 31, 2025. 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, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by an experienced executive team collaborating with world-class researchers and technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices, including digital assets, to maximize stakeholder value. More information is available at and X: @ArteloBio. About ART26.12 ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Human studies with ART26.12 have demonstrated a favorable safety pro no serious adverse events, as well as predictable, linear pharmacokinetics and dosing flexibility in both fed and fasted states. Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. In addition to ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. About ART27.13 ART27.13 is a novel cannabinoid receptor agonist being developed as supportive care for people with cancer experiencing anorexia and cachexia. Administered orally once daily, the treatment goals with ART27.13 are to improve appetite, body weight, and activity levels while preserving muscle and elevating quality of life. Initially developed by AstraZeneca plc, ART27.13 selectively targets peripheral cannabinoid (CB 1 and CB 2 ) receptors to avoid the psychoactive side effects typically associated with some cannabinoids. While exhibiting a favorable safety pro all doses in the CAReS trial, interim analysis from the blinded and randomized Phase 2 study demonstrated a mean weight gain of over 6% for participants that received the top dose of ART27.13 compared to a 5% loss in the placebo group. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to therapy. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. About CAReS The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in people with cancer experiencing 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. Interim data from the Phase 2 portion of CAReS showed improvements in lean body mass, weight gain, and activity among patients treated with all doses of ART27.13, particularly at the highest dose, compared to the participants administered placebo. (ISRCTN registry: ) About ART12.11 ART12.11 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. Artelo has received favorable UK MHRA regulatory guidance supporting Phase 1 study plans and potential accelerated pathways with plans to initiate human clinical studies in the first half of 2026. Greatly enhanced pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability pro 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 and has now been granted or validated in 21 additional countries. 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 statements 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, LLC Tel: 212-671-1020 Email: ARTL@crescendo-ir.com

临床结果临床1期临床2期财报

2025-11-12

·GlobeNewswire-Health Care

Artelo Biosciences Provides Business Update and Reports Third Quarter 2025 Financial Results

Encouraging Clinical Progress, Including Positive Interim Phase 2 Results for the Treatment of Cancer Anorexia Cachexia SyndromeSOLANA BEACH, Calif., Nov. 12, 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, dermatologic, or neurological conditions, today provided a business update and announced its financial and operational results for the three months ended September 30, 2025. “We continue to deliver on our clinical and strategic objectives, advancing three differentiated programs with strong potential to address large, underserved markets,” said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “We were very pleased with the interim Phase 2 data with ART27.13 showing restoration in body weight versus continued weight loss in people suffering from cancer-related anorexia. Importantly, this data has attracted meaningful partnering interest from several pharmaceutical companies. In addition, partnering interest continues to expand for ART26.12, our lead FABP5 inhibitor, as more companies become aware of its broad therapeutic potential. With ART26.12’s progress toward a multiple ascending dose study, we believe our clinical pipeline is well-positioned to create substantial value for patients and shareholders.” Business Highlights: ART26.12 – Following Successful Single Ascending Dose (SAD) Study, Multiple Ascending Dose (MAD) Study Protocol being Finalized The MAD study aims to confirm the favorable safety profile and dose-linear pharmacokinetics observed in the SAD study under multiple dose scenarios while providing further information on dosing frequency and biomarker strategy.Preliminary food-effect results support future development with dosing in either fed or fasted states. ART27.13 –Positive Interim Phase 2 CAReS Data Driving Partnering Interest Interim Phase 2 Cancer Appetite Recovery Study (CAReS) results demonstrated meaningful efficacy, safety, and functional benefit in cancer-related anorexia and weight loss. Patients receiving top dose ART27.13 achieved an average +6.4% weight gain versus a -5.4% loss on placebo, showed +4.2% lean body mass increase, and improved activity levels aligned with potential regulatory endpoints.ART27.13 was well tolerated with predominantly mild or moderate adverse events. Following positive Phase 2 results and coverage by UK and USA media outlets, Artelo has received multiple expressions of potential collaboration interest from global and regional pharmaceutical companies.European Patent Office issued a Notice of Allowance covering the intended commercial formulation of ART27.13 through 2041. ART12.11 – First-in-Human Study Expected to Commence in 1H 2026 Received clear guidance from MHRA, the regulatory authority in the UK, on a streamlined pathway to the clinic. First-in-human study anticipated to start in first half of 2026.Presentation of new preclinical data at the 35th Annual International Cannabinoid Research Society Symposium demonstrating an antidepressant-like activity on par with and improved cognitive benefits over sertraline (Zoloft®); a leading standard-of-care therapy.Publication of new preclinical data conducted in collaboration with researchers at Western Ontario University in Progress in Neuro-Psychopharmacology and Biological Psychiatry, which highlighted that ART12.11 significantly outperformed cannabidiol (CBD) alone in reducing stress-induced depression and anxiety symptoms, while also achieving superior oral bioavailability. Q3 2025 Financial Results (Unaudited) R&D Expenses: Research and development expenses were $1.3 million for the quarter ended September 30, 2025, compared to $0.3 million for the same period in 2024, during which $1.3 million of UK tax credits were received.G&A Expenses: General and administrative expenses were $1.8 million for the quarter ended September 30, 2025, compared to $0.9 million in 2024.Net Loss: For the quarter ended September 30, 2025, net loss was $3.1 million, or $3.97 per basic and diluted common share, which included $0.4 million of non-cash expenses, compared to a net loss of $1.1 million, or $2.10 per basic and diluted common share for the quarter ended September 30, 2024, which included $0.2 million of non-cash expenses.Cash and Investments: Cash and investments totaled $1.7 million as of September 30, 2025.In July 2025, the Company entered into an At-The-Market Offering Agreement under which the Company can offer and sell up to $6.5 million of shares of common stock from time to time through an “at the market” offering program. During the quarter ended September 30, 2025, common stock was sold under the agreement for gross proceeds of $0.4 million.In September 2025, the Company completed a confidentially marketed public offering of common stock with gross proceeds of $3.0 million. About ART26.12ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) under an investigational new drug application opened with the FDA. Fatty Acid Binding Proteins (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 a number of 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, psoriasis, and anxiety disorders. About ART27.13ART27.13 is a novel benzimidazole derivative being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. A statistically significant and dose-dependent increase in body weight was observed in people 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 conducting a Phase 2 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 1/2 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 1 portion of the CAReS study was designed to determine the most effective and safest dose of ART27.13 for dosing in the Phase 2 stage. Currently enrolling, the Phase 2 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 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. Greatly enhanced 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 and has now been granted or validated in 19 additional countries. 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, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by an experienced executive team collaborating with world-class researchers and technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices, including digital assets, to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio. Forward Looking StatementsThis 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

临床2期临床结果临床1期财报

2025-10-15

·ir.artelobio.com

Artelo Biosciences Announces Expanded Clinical Data to be Presented on both ART26.12 and ART27.13 at the 8th Annual Cannabinoid & Endocannabinoid Drug Development Summit

ART26.12 Phase 1 Data Demonstrated No Safety Concerns, Predictable Linear Plasma Exposure, and Options for Dosing in Either Fed or Fasted Conditions ART27.13 Interim Phase 2 Data Showed Substantial Weight Gain and Activity Improvements in the Treated Patients versus Placebo SOLANA BEACH, Calif., Oct. 15, 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, dermatologic, or neurological conditions, today announced that Professor Saoirse O’Sullivan, Vice President of Translational Sciences at Artelo Biosciences, is presenting expanded data from Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, ART26.12, Single Ascending Dose (SAD) Study at the 8th Annual Cannabinoid & Endocannabinoid Drug Development Summit, taking place October 15–16, 2025, in Boston, Massachusetts. In addition, Professor O’Sullivan will be giving additional insights on ART27.13 development progress in cancer-related anorexia with interim data from the Phase 2 portion of the Cancer Appetite Recovery Study (CAReS). During the presentation titled Exploring the Clinical Development of the Fatty Acid Binding Protein 5 (FABP5) Inhibitor ART26.12, Professor O’Sullivan plans to share findings from the Company’s SAD study and preliminary food effect investigation with ART26.12, which evaluated the safety, tolerability, and pharmacokinetics of its FABP5 inhibitor in healthy volunteers. The SAD study demonstrated that ART26.12 at single doses up to 1050 milligrams was safe and well tolerated. Importantly, ART26.12 exhibited predictable linear dose exposure and showed potential dosing flexibility in either fed or fasted states for future studies. These findings support Artelo’s belief that advancement of ART26.12 into multiple ascending dose and proof-of-principle pain studies is warranted. In addition, Professor O’Sullivan will discuss detailed interim data from the CAReS Phase 2 study. In CAReS, Artelo is evaluating ART27.13, the Company’s proprietary dual cannabinoid agonist, versus placebo in a randomized and blinded comparison in cancer patients experiencing anorexia and weight loss. Initial findings show patients receiving up to 1300 micrograms daily on average gained over 6% in weight versus placebo participants losing an additional 5%. Despite receiving up to twice the maximum dose delivered in the Phase 1 stage of CAReS, the safety profile in Phase 2 to date has been similar and well-tolerated. ART27.13 is uniquely positioned as the most clinically advanced small-molecule, orally administered once-daily treatment in development for cancer anorexia. Impacting up to 80% of late-stage cancer patients, currently there are no approved treatments in the US, UK or EU. Regarding Artelo’s innovation leadership and progress in cannabinoid and lipid-signaling therapeutics development, Professor Saoirse O'Sullivan stated, "Having spent my entire career researching the potential medical benefits of modifying the endocannabinoid system, it is gratifying as a scientist and affirming of our research initiatives to be at the Cannabinoid & Endocannabinoid Drug Development Summit presenting two positive clinical studies for two of Artelo’s development candidates that have the potential to impact the devastating effects of peripheral neuropathic pain and anorexia and cachexia syndrome for people living with cancer." About ART26.12 ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) under an investigational new drug application opened with the FDA. Fatty Acid Binding Proteins (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 a number of 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, psoriasis, and anxiety disorders. About ART27.13 ART27.13 is a novel benzimidazole derivative being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. A statistically significant and dose-dependent increase in body weight was observed in people 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 conducting a Phase 2 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 CAReS The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 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. The Phase 1 portion of the CAReS study was designed to determine the most effective and safest initial dose of ART27.13 in the Phase 2 stage. The Phase 2 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 compared to placebo. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817) 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, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by an experienced executive team collaborating with world-class researchers and technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices, including digital assets, to maximize stakeholder value. More information is available at www.artelobio.com and X: @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. 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, LLC Tel: 212-671-1020 Email: ARTL@crescendo-ir.com Released October 15, 2025

临床2期临床结果临床1期

100 项与 ART27.13 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
厌食症	临床2期	爱尔兰	Artelo Biosciences Ltd.	2021-10-01
厌食症	临床2期	挪威	Artelo Biosciences Ltd.	2021-10-01
厌食症	临床2期	英国	Artelo Biosciences Ltd.	2021-10-01
恶病质	临床2期	英国	Artelo Biosciences, Inc.	2021-04-12
疼痛	临床2期	美国	AstraZeneca PLC	2008-04-10
癌症疼痛	临床1期	加拿大	Neomed Institute	2013-12-09
肿瘤	临床前	加拿大	Artelo Biosciences, Inc.	2018-01-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ISRCTN15607817 (CAReS, Company_Website) 人工标引	临床2期	厌食症	-	ART27.13 (titrated to the highest dose (1300 µg))	齋廠壓獵鏇鬱廠顧襯糧(製膚齋廠鏇廠鹽膚積蓋) = 膚簾製製膚壓餘鹽範廠築鹹構膚齋積簾廠蓋築 (餘蓋網糧鏇憲醖願願鹽 )	积极	2025-09-29
				Placebo	齋廠壓獵鏇鬱廠顧襯糧(製膚齋廠鏇廠鹽膚積蓋) = 窪淵遞淵膚艱繭遞齋顧築鹹構膚齋積簾廠蓋築 (餘蓋網糧鏇憲醖願願鹽 )
ISRCTN15607817 (CAReS, Company_Website)	临床2期	恶病质	18	ART27.13	鬱膚鬱憲憲壓鏇繭範齋(壓網願餘蓋觸願醖築製) = 醖築夢鏇糧鹽鹹憲憲艱衊製鏇鬱選糧壓願蓋襯 (觸鹽顧鬱製繭襯襯選簾 ) 更多	积极	2025-09-03
				placebo	鬱膚鬱憲憲壓鏇繭範齋(壓網願餘蓋觸願醖築製) = 獵鑰廠膚顧願蓋艱壓壓衊製鏇鬱選糧壓願蓋襯 (觸鹽顧鬱製繭襯襯選簾 ) 更多
ISRCTN15607817 (CAReS, GlobeNewswire) 人工标引	临床1期	厌食症	-	ART27.13	廠觸憲憲積繭窪蓋廠蓋(築蓋遞簾壓壓構顧餘製) = only mild to moderate adverse events observed in a minority of participants. No serious or life-threatening adverse events were recorded. 構襯糧顧願蓋夢獵鏇襯 (憲獵繭淵艱願鹹壓範網 ) 更多	积极	2024-12-09