Core Insights - Artelo Biosciences, Inc. has announced favorable results from its first-in-human study of ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5), which shows promising safety and pharmacokinetic profiles [1][4][5] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions including cancer and pain [1][8] - The company is advancing a portfolio of therapeutics aimed at addressing significant unmet needs in multiple diseases and conditions [8] Product Development - ART26.12 is the first orally administered, selective, and peripherally restricted FABP5 inhibitor to enter human clinical evaluation, targeting chronic pain management [4][5] - The Phase 1 Single Ascending Dose (SAD) study enrolled 49 healthy volunteers to assess the safety, tolerability, and pharmacokinetics of ART26.12 [2][5] Market Opportunity - The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is projected to surpass $159 billion by 2030, driven by increasing prevalence of conditions such as neuropathic pain and arthritis [5] - There is a significant gap in innovation for non-opioid therapies in the pain management market, which ART26.12 aims to fill with its unique mechanism of action [5] Safety and Efficacy Findings - All adverse events reported in the study were mild, transient, and self-resolving, with no drug-related adverse events observed [7] - The pharmacokinetic profile showed dose-dependent, linear absorption, indicating a predictable response to the drug [7] - A wide safety margin was observed between estimated therapeutic plasma concentrations and the highest exposure levels achieved, supporting potential titration for maximum efficacy [7] Future Development Plans - A Multiple Ascending Dose study is expected to commence in the fourth quarter of this year to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing [5]

Core Insights - Viatris Inc. announced positive results from its Phase 3 trials for MR-107A-02, a fast-acting formulation of meloxicam, demonstrating significant pain relief compared to placebo and reduced opioid usage [1][2][3] - The company plans to submit a New Drug Application to the U.S. FDA by the end of 2025 based on these results [1][5] Group 1: Study Results - Both Phase 3 trials met primary endpoints, showing statistically significant and clinically meaningful improvement in pain management [2][4] - In the herniorrhaphy trial, the least squares mean difference in pain intensity (SPID0-48h) between MR-107A-02 and placebo was 50.1 (95% CI: 35.4, 64.8; p<0.001), while in the bunionectomy trial, it was 82.7 (95% CI: 62.0, 103.4; p<0.001) [4] - MR-107A-02 resulted in a higher percentage of opioid-free patients: 72.6% in herniorrhaphy versus 58.6% in placebo (p=0.002) and 56.9% in bunionectomy versus 33.1% in placebo (p<0.001) [4] Group 2: Efficacy and Safety - The treatment was well tolerated, with adverse events comparable to placebo, and no deaths reported [4] - The drug showed superior pain control compared to the opioid comparator (tramadol) in both surgical models, with faster onset of pain relief [4][3] Group 3: Future Plans - Viatris aims to present full results from the Phase 3 studies at upcoming conferences, including PAINWeek 2025 [5] - The company is building on previous Phase 2 data from dental pain studies to support its application for MR-107A-02 [5][10]

Company Overview - Channel Therapeutics Corporation is a clinical-stage biotechnology company focused on developing and commercializing novel, non-opioid, non-addictive therapeutics to alleviate pain [3] - The company's initial clinical focus is on selectively targeting the sodium ion-channel known as NaV1.7 for the treatment of various types of chronic pain, acute and chronic eye pain, and post-surgical nerve blocks [3] Financial Disclosure - The company disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024, that the audited financial statements included an audit opinion from its independent registered public accounting firm that contained a going concern emphasis of matter paragraph [1] - This announcement does not represent any change or amendment to the company's consolidated financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2024 [2] Regulatory Compliance - The release of this information is required by Sections 410(h) and 610(b) of the NYSE American LLC Company Guide [2]