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Artelo Biosciences Receives Favorable UK MHRA Guidance for a Phase 1 Trial of ART12.11, the Company's Proprietary CBD:TMP Cocrystal Being Developed for the Treatment of Anxiety and Depression
Artelo Biosciences Receives Favorable UK MHRA Guidance for a Phase 1 Trial of ART12.11, the Company's Proprietary CBD:TMP Cocrystal Being Developed for the Treatment of Anxiety and Depression

Associated Press

time01-08-2025

  • Business
  • Associated Press

Artelo Biosciences Receives Favorable UK MHRA Guidance for a Phase 1 Trial of ART12.11, the Company's Proprietary CBD:TMP Cocrystal Being Developed for the Treatment of Anxiety and Depression

SOLANA BEACH, Calif., Aug. 01, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. ('Artelo' or the 'Company') (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 it has received written scientific advice from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) on the nonclinical development and first-in-human (FIH) clinical study plans for ART12.11, a novel cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP). The MHRA agreed that reliance on the substantial body of historic nonclinical and clinical evidence for CBD, alongside legacy data for TMP, provides a scientifically justified basis for a streamlined clinical trial application (CTA)-enabling nonclinical development plan of the cocrystal combination to support the proposed FIH study, with clear guidance for achieving the agreed-upon FIH study design for ART12.11. The agency also affirmed that the proposed first-in-human (FIH) study design—a single-dose, multi-formulation crossover study—was methodologically sound for characterizing ART12.11's pharmacokinetic profile. Importantly, the MHRA offered constructive and specific guidance for completing the data package supporting the agreed-upon Phase 1 trial. Additionally, the agency proposed that ART12.11 may be a candidate for the Innovative Licensing and Access Pathway (ILAP). ILAP offers a unique opportunity to accelerate the development and patient access of promising new therapies through early and sustained collaboration with the MHRA, National Health Service, and health technology assessment bodies. Given ART12.11's novel mechanism and potential to address unmet needs in anxiety and depression, Artelo believes the program aligns well with ILAP's criteria and will evaluate a formal application to enter the pathway in the coming months. 'It's gratifying to receive this positive feedback and actionable recommendations from the MHRA, which provides a clear path forward as we prepare to initiate clinical studies with ART12.11,' said Dr. Andrew Yates, Chief Scientific Officer at Artelo. 'The recommendation to explore ILAP reinforces the proposition of ART12.11 as a novel drug with the potential to transform the treatment landscape for anxiety and depression.' Multiple nonclinical studies with ART12.11 have shown its promising profile compared to an antidepressant or CBD alone. The Company recently announced positive preclinical results in a depression model comparing ART12.11 with sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), where Artelo's patented CBD:TMP cocrystal demonstrated efficacy on par with sertraline and showed superior cognitive restoration compared to the leading SSRI. Additionally, in a rodent model of stress-induced anxiety and depression, where ART12.11 was compared to CBD dosed at 300% the amount of CBD contained in the oral tablet of ART12.11, the CBD:TMP cocrystal demonstrated efficacy where CBD alone did not. 'The clear regulatory assurance from the regulatory authority in the UK is expected to reduce expenses for our ART12.11 program,' added Gregory Gorgas, President & CEO at Artelo. 'We are especially pleased with the potential for an accelerated development strategy which could greatly accelerate our progress with ART12.11 and could provide for a longer period of market exclusivity as our patents are valid in 20 countries through the end of 2038. Over the next few months we look forward to finalizing our preparations to enter the clinic with ART12.11 early next year.' 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. 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 in a solid dosage form may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The U.S. 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. 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 and Twitter: @ArteloBio. Forward Looking Statements Investor Relations Contact: Crescendo Communications, LLC Tel: 212-671-1020 Email: [email protected]

Artelo Biosciences files to sell 920K shares of common stock for holders
Artelo Biosciences files to sell 920K shares of common stock for holders

Business Insider

time12-07-2025

  • Business
  • Business Insider

Artelo Biosciences files to sell 920K shares of common stock for holders

17:34 EDT Artelo Biosciences (ARTL) files to sell 920K shares of common stock for holders Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.

Artelo Biosciences Announces Positive Preclinical Efficacy with ART12.11 in Stress-Induced Depression Model
Artelo Biosciences Announces Positive Preclinical Efficacy with ART12.11 in Stress-Induced Depression Model

Yahoo

time07-07-2025

  • Health
  • Yahoo

Artelo Biosciences Announces Positive Preclinical Efficacy with ART12.11 in Stress-Induced Depression Model

ART12.11, the Patented CBD:TMP Cocrystal, Demonstrates Potent Antidepressant-Like Activity and Cognitive Benefits Over Leading SSRI Data Being Presented at the 35th Annual International Cannabinoid Research Society Symposium SOLANA BEACH, Calif., July 07, 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, dermatological or neurological conditions, today announced the presentation of compelling new preclinical data on its Cannabidiol (CBD) and Tetramethylpyrazine (TMP) cocrystal drug candidate, ART12.11, at the 35th Annual International Cannabinoid Research Society (ICRS) Symposium, taking place July 6–10 in Bloomington, Indiana. The poster, titled 'ART12.11, A Novel Cannabidiol:Tetramethylpyrazine Cocrystal, Alleviates Stress-Induced Depressive Symptoms,' is being presented today by Matt Jones, a scientist working in the laboratory of Professor Steven Laviolette at the University of Western Ontario, Canada. The data highlight ART12.11's unique dual-action profile in improving depression-related behaviors in animals and reversing cognitive deficits associated with chronic stress. These are key differentiators that position ART12.11 as a potential next-generation treatment candidate in the multi-billion-dollar antidepressant market. Highlights: Robust Antidepressant-like Effects: A 28-day treatment regimen with ART12.11 significantly reversed behavioral impairments in male rats exposed to chronic stress. The data with ART12.11 demonstrated efficacy on par with sertraline (Zoloft), a leading selective serotonin reuptake inhibitor (SSRI). Restoration of Hedonic and Social Behaviors: Like sertraline, ART12.11 improved sucrose preference and social motivation, which are established behavioral markers of depressive-like states, to near-baseline levels. Superior Cognitive Restoration: Unlike sertraline, ART12.11 reversed stress-induced deficits in both spatial and short-term memory without negatively impacting social memory. Differentiated Therapeutic Profile: These findings underscore ART12.11's potential as a highly differentiated candidate for treating depression and anxiety, especially in patients where cognitive dysfunction occurs, which is a known limitation of existing SSRI therapies. 'Our latest behavioral studies suggest that the cocrystal holds strong potential as a novel antidepressant. In a stressed rodent model, ART12.11 significantly restored key depression-related behaviors to baseline levels. The ability to experience pleasure and social motivation with ART12.11 were comparable to the effects of the established antidepressant sertraline. Notably, ART12.11 also reversed stress-induced cognitive impairments, which is an area where sertraline was not as effective,' said Matt Jones, the lead researcher of this work at the University of Western Ontario. Prior preclinical research studies in animals with ART12.11 demonstrated greater behavioral and pharmacokinetic results compared to CBD or Epidiolex. These new findings observed in Dr. Laviolette's laboratory are from the first preclinical study that compared ART12.11 to a leading SSRI. 'Although strong antidepressant effects were noted with ART12.11 in prior studies, we are especially encouraged by these comparative findings,' said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. 'We believe ART12.11 has the potential to meet a critical need in the mental health landscape by delivering both mood-lifting and cognitive benefits. which could set ART12.11 apart from existing antidepressants.' 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 and has now been granted or validated in 19 additional countries. About Artelo BiosciencesArtelo 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 and X: @ArteloBio. About the International Cannabinoid Research SocietyThe International Cannabinoid Research Society (ICRS) is the premier global scientific association with more than 650 international members from 40 countries, all active researchers in the field of endogenous, plant-derived, and synthetic cannabinoids and related bioactive lipids. In addition to acting as a source for impartial information on cannabis and the cannabinoids, the main role of the ICRS is to provide an open forum for researchers to meet and discuss their research. The ICRS Symposium is being held July 6-10, 2025 in Bloomington, IN. Interested parties may follow @ICRS_Society on X. 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 future investment policy of its excess capital, 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@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Artelo Biosciences Announces Positive First-in-Human Data for ART26.12, a Novel Non-Opioid Treatment Candidate for Persistent Pain
Artelo Biosciences Announces Positive First-in-Human Data for ART26.12, a Novel Non-Opioid Treatment Candidate for Persistent Pain

Associated Press

time30-06-2025

  • Business
  • Associated Press

Artelo Biosciences Announces Positive First-in-Human Data for ART26.12, a Novel Non-Opioid Treatment Candidate for Persistent Pain

First Orally Active Fatty Acid Binding Protein 5 Inhibitor Evaluated in Humans First-in-Class Approach Targets Unmet Need in Multibillion-Dollar Pain Management Market SOLANA BEACH, Calif., June 30, 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, dermatological or neurological conditions, today announced favorable results from its first-in-human study evaluating ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5). The results affirm the promising safety and pharmacokinetic (PK) profile previously observed in preclinical studies. Inhibiting FABP5 represents a unique mechanism of action with ART26.12 standing out as a first-in-class candidate in the field of pain management. The Phase 1 Single Ascending Dose (SAD) study was designed to assess the safety, tolerability, and pharmacokinetics of ART26.12 in healthy volunteers. The SAD study enrolled 49 subjects. The key findings include: Andrew Yates, Ph.D., Senior Vice President and Chief Scientific Officer at Artelo, commented, 'We are greatly encouraged with the results of the SAD study with our lead FABP5 inhibitor and we are particularly pleased to observe that the safety and PK profile that had been generated from ART26.12's non-clinical studies translated well to the human experience.' ART26.12 is the first orally administered, selective, and peripherally restricted FABP5 inhibitor to enter human clinical evaluation. By targeting FABP5, ART26.12 modulates endogenous lipid signaling molecules that exert analgesic effects through established pathways, including TRPV1, PPAR alpha, and cannabinoid receptors, with additional mechanisms such as Nav1.8 under investigation. The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is expected to surpass $159 billion by 20301, driven by the increasing prevalence of conditions such as neuropathic pain, arthritis, and fibromyalgia. Despite the scale of the market, innovation remains sparse—particularly for non-opioid therapies. As part of the U.S Food and Drug Administration's Overdose Prevention Framework, the Agency has issued draft guidance aimed at encouraging the development of non-opioid analgesics for pain. ART26.12 is positioned to fill this gap with an innovative mechanism of action and favorable safety profile. A Multiple Ascending Dose study to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing over time is expected to commence in the fourth quarter this year. About ART26.12 ART26.12, Artelo's lead FABP5 inhibitor, is being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic. The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN). 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 several 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, anxiety disorders, and psoriasis. ART26.12 has been included in Helping to End Addiction Long-term® (HEAL) Initiative's Preclinical Screening Platform for Pain program of the U.S. National Institutes of Health. The HEAL program is dedicated to advancing non-opioid solutions to pain and curbing opioid use disorder. 1 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 and X: @ArteloBio. Forward-Looking StatementsInvestor Relations Contact: Crescendo Communications, LLC Tel: 212-671-1020 Email: [email protected]

Artelo Biosciences Inc trading halted, news pending
Artelo Biosciences Inc trading halted, news pending

Business Insider

time13-06-2025

  • Business
  • Business Insider

Artelo Biosciences Inc trading halted, news pending

19:50 EDT Artelo Biosciences (ARTL) Inc trading halted, news pending Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>

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