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Aether Therapeutics has completed preclinical toxicology and safety studies for its lead compound ATX-001 (6β-Naltrexol/6BMX), a metabolite of naltrexone with distinct properties. The compound has shown oral bioavailability and safety in animal models, prevents dependence in mice and guinea pigs, and prevents NOWS in guinea pig neonates. Two exploratory FDA-cleared clinical trials of intravenous 6β-Naltrexol have demonstrated safety in humans. Preclinical work is complete; pre-IND submission to the FDA anticipated by Q4 2024 with Phase I trials expected to begin in the first half of 2025
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