Artelo Biosciences (Nasdaq: ARTL) has announced positive results from its first-in-human Phase 1 Single Ascending Dose (SAD) study of ART26.12, a novel non-opioid pain treatment candidate. The study, involving 49 subjects, demonstrated favorable safety and pharmacokinetic profiles for the first orally active Fatty Acid Binding Protein 5 (FABP5) inhibitor tested in humans.
Key findings from the study include excellent safety results with only mild, transient, and self-resolving adverse events, predictable pharmacokinetics with dose-dependent linear absorption, and a wide safety margin between therapeutic plasma concentrations and highest exposure levels. The drug represents a first-in-class approach targeting the multibillion-dollar pain management market.
The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is projected to surpass $159 billion by 2030. A Multiple Ascending Dose study is planned to commence in Q4 2025 to further evaluate ART26.12's safety, tolerability, and pharmacokinetics with repeated dosing.
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