Achieve Life Sciences Inc ACHV 11.08% shares are skyrocketing as the clinical-stage biotech moves one step closer to filing a New Drug Application for its smoking cessation pipeline candidate cytisine.
The stock was rallying 33.15 percent to $4.82 Wednesday morning.
What Happened
After a meeting with the FDA regarding both clinical and non-clinical development plans for cytisine, Achieve Life Sciences said the Phase 3 clinical program as well as a future NDA filing are further defined.
In late June, the company reported positive results for cytisine based on a series of drug metabolism, drug-to-drug interaction and transponder studies.
Why It’s Important
Cytisine is a plant-based alkaloid which binds to the nicotinic acetylcholine receptor. It has been approved and marketed in central and eastern Europe for over 15 years and has helped over 20 million people tackle nicotine addiction, according to Achieve.
What’s Next
The company said it will conduct a Phase 2b optimization trial in about 250 smokers in the U.S., with various dosing schedules to determine efficacy, safety and compliance profiles. The primary endpoint is a reduction in cigarettes consumed during treatment.
Achieve Life Sciences said it will initiate the Phase 2b trial in Q4’18, with top-line results expected in Q2’19. The results will help define the Phase 3 study, which is planned to be initiated in 2019.
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