SOLANA BEACH, Calif. - Artelo Biosciences , Inc. (NASDAQ:ARTL), a clinical-stage biopharmaceutical company, today announced promising preliminary results from its Cancer Appetite Recovery Study (CAReS) involving ART27.13, a treatment for cancer-related anorexia. The findings were presented at the 17th International Conference on Sarcopenia, Cachexia, & Wasting Disorders.
ART27.13, a benzimidazole derivative, is being investigated in a randomized, placebo-controlled Phase 1/2 trial. In Phase 1, the drug was administered at doses ranging from 150 to 650 micrograms and showed tolerability with only mild to moderate side effects in a minority of participants. No severe adverse events were reported. Notably, after one month of treatment, two-thirds of the participants demonstrated either stabilization or reversal of cancer-associated weight loss.
The Phase 2 trial, which is currently enrolling participants, is exploring a starting dose of 650 micrograms with potential increases every four weeks, up to 1300 micrograms per day. The study aims to measure the impact on lean body mass, weight gain, quality of life, and safety, with an additional focus on activity levels via a wearable monitor.
Professor Barry J. A. Laird, who presented the data, remarked on the significance of the results in advanced cancer patients, particularly given the lack of approved treatments for cancer-related anorexia in the UK, US, or Europe. Wall Street appears optimistic about the company's potential, with analysts setting price targets between $5 and $6 per share, suggesting significant upside potential from current levels.
ART27.13 has previously shown promise in preclinical research for protecting against muscle degeneration in cancer cachexia conditions. Steven D. Reich, MD, Chief Medical (TASE:PMCN) Officer at Artelo Biosciences, expressed optimism about the drug's potential for treating appetite and weight loss in cancer patients.
Enrollment for the Phase 2 portion of the CAReS study is expected to complete in the first half of 2025. ART27.13 is a once-daily oral drug that acts on CB1 and CB2 receptors and has been studied in over 250 participants to date.
The information presented is based on a press release statement from Artelo Biosciences.
In other recent news, Artelo Biosciences reported significant developments in its pharmaceutical pipeline. The company received a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA), marking the commencement of a Phase 1 clinical trial for its drug candidate ART26.12. This drug, aimed at treating chemotherapy-induced peripheral neuropathy (CIPN), is eagerly anticipated, with results expected in the first half of 2025.
Artelo Biosciences also presented pre-clinical data for its cannabinoid-based compound, ART12.11, which has shown a pharmacokinetic profile similar to FDA-approved Epidiolex. The company is developing an optimized tablet form of ART12.11, which is expected to offer precise dosing and easier storage.
In addition to these developments, Artelo Biosciences is exploring the potential of fatty acid binding protein 7 (FABP7) in various cancers and is developing a library of FABP inhibitor compounds. The most advanced compound, ART26.12, has shown promise in preclinical studies for cancer and related conditions.
EF Hutton recently initiated coverage on Artelo Biosciences, assigning the stock a Buy rating and setting a price target of $6.00. The firm's analysis underscored the potential of Artelo's programs and the strategic steps the company must undertake, emphasizing the importance of raising capital for the company's development. These recent developments underscore Artelo Biosciences' ongoing efforts to address significant unmet medical needs with its product candidates.
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