Prior to the opening bell, Achieve shares jumped 43% to US$5.17.
A recent meeting with the US Food and Drug Administration makes clear the next stages required before Achieve can bring cytisine to market.
“The successful outcome of our discussions with the FDA has provided us with clarity and direction to better inform our Phase 3 clinical development program and our efforts toward expanding cytisine availability,” said Rich Stewart, chief executive of Achieve Life Sciences.
Taking into account the FDA’s recommendations, Achieve is now set to conduct a Phase 2b optimization trial, which will evaluate 250 smokers in the US and use various cytisine dosing schedules over a 25-day period.
The primary goal of the trial will be to see if the number of cigarettes smoked during treatment is reduced.
Cytisine is a plant-based alkaloid with a high-binding affinity to the nicotinic acetylcholine receptor. It has been used as a smoking cessation treatment across Central and Eastern Europe for more than 15 years.
Achieve will kick off its Phase 2b trial in the fourth quarter of this year and expects to report top-line results for the study by the second quarter of next year.
Once the results from this Phase 2b trial are released, Achieve plans to begin its Phase 3 program for cytisine next year.