atai Life Sciences Announces Positive Initial Results for Phase 1 Trial of KUR-101, an Oral Formulation of Mitragynine for OUD

atai Life Sciences has announced positive initial results for their Phase I clinical trial of KUR-101. KUR-101 is an oral formulation of deuterated mitragynine, the major active alkaloid of the kratom plant, under development for the treatment of opioid use disorder (OUD).

Initial results indicate that KUR-101 is safe and generally well-tolerated. Results also showed a dose-proportional pharmacokinetic (PK) profile that was unaffected by food. In the single ascending oral dose portion of the trial, no severe or serious adverse events were reported, with most treatment-related adverse events being mild. Changes in respiratory rate following treatment with KUR-101 were comparable to that of placebo-treated patients for the doses tested and comparable across doses.