Altimmune (NASDAQ:ALT) has successfully completed its multiple dose toxicity and toxicokinetic studies of ALT-801, a GLP-1/glucagon dual receptor agonist for the treatment of non-alcoholic steatohepatitis (NASH).
ALT-801 was well tolerated in both rats and cynomolgus monkeys and no-observed-adverse-effects were seen.
The most remarkable finding was significant weight loss versus the control groups in both species. No evidence of significant GI toxicity or intolerability, including vomiting, was observed in the animals.
Recently completed toxicology studies also suggest that ALT-801 can be well tolerated in humans and not require dose titration, potentially enabling higher levels of weight loss and liver fat reduction than existing GLP-1 receptor agonist-based compounds.
The nonhuman primate data also showed an ALT-801 pharmacokinetic profile that is expected to support weekly dosing in humans.
Based on these preclinical toxicology studies, Altimmune plans to initiate first-in-human studies of ALT-801 in Q4, with data readouts on safety, pharmacokinetics, and important measures of activity such as weight loss and liver fat reduction in the Spring of 2021.
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