Achieve Life Sciences announces completion of MTD study
Achieve Life Sciences announced completion of their maximum tolerated dose, or MTD, study. The results indicate a lack of dose-limiting toxicity as defined by protocol criteria even at the highest 30 mg single, oral dose of cytisinicline evaluated in the study. This study, initiated in March, is required by the FDA as part of a New Drug Application, or NDA, for marketing approval in the United States. It was designed to determine dose-limiting adverse events, or AEs, and to define the maximum tolerated dose for a single, oral dose of cytisinicline. An independent Data Safety Monitoring Committee, or DSMC, composed of the Study Investigator and two independent physicians evaluated all safety outcomes before each dose escalation. Stopping criteria for further dose escalation was defined as the occurrence of severe or serious AEs or any other safety information considered as a concern. The starting dose was 6 mg, which increased in 3 mg increments up to 21 mg. When the MTD was not reached at 21 mg, the study was amended to evaluate doses up to 30 mg. At this dose, the stopping criteria of serious or severe AEs were still not met, but the DSMC recommended stopping the study. The results will be reviewed with the FDA to determine if further escalation beyond 30 mg will be required.