Achieve Life Sciences Inc (NASDAQ:ACHV) shares swirled a bit higher Tuesday as the biotech revealed that the data safety monitoring committee (DSMC) had no issues with its trial of smoking-cessation drug cytisinicline.
The Phase 2b trial called ORCA-1 should continue, it said, while topline efficacy and safety data are expected by the end of the second quarter of 2019.
Cytisinicline is a plant-based alkaloid and has been an approved, branded product in Central and Eastern Europe for more than two decades to help combat nicotine addiction.
The data safety committee has reviewed the ORCA-1 data twice during the study, and has concluded following each review that there are no safety concerns for subjects or study conduct issues.
The trial is evaluating a 25-day treatment course of 1.5 mg or 3 mg doses of cytisinicline using either a declining titration schedule or three times daily. The trial is randomized and blinded to compare the effectiveness of the cytisinicline doses and schedules to respective placebo groups.
The primary efficacy endpoint is the overall reduction in the number of cigarettes smoked during the treatment period.
Shares in Achieve Life Sciences added 1.8% in New York to stand at $3.23