Investors love biotech stocks for the lottery ticket-like returns they can offer if a company wins the regulator’s blessing. Case in point: Achieve Life Sciences (NASDAQ:ACHV), whose shares are skyrocketing over 30% on Wednesday.
Why the excitement? The clinical-stage pharmaceutical company announced a positive update on its cytisine development program following a meeting conducted with the FDA. The meeting with the FDA on the non-clinical and clinical development plans has further defined Achieve’s Phase 3 clinical program and expected future New Drug Application (NDA) submission.
Based on the FDA’s recommendations to further characterize cytisine dosing prior to NDA submission, Achieve plans to conduct a Phase 2b optimization trial in approximately 250 smokers in the U.S., with various cytisine dosing schedules to evaluate overall treatment efficacy, safety, and compliance profiles for cytisine.
The Central and Eastern European commercially-approved cytisine dose is 1.5 mg on a declining titration dose over 25-days. The planned Phase 2b trial will evaluate additional dosing of 3.0 mg cytisine using the same 25-day titration schedule, as well as 1.5 mg and 3.0 mg cytisine dosing using a three times daily dosing schedule. The study will be randomized and blinded to compare the effectiveness of all doses and schedules of cytisine to placebo. The primary endpoint of the trial will be reduction in the number of cigarettes consumed during treatment. Achieve plans to initiate this Phase 2b trial in the fourth quarter of 2018 with top line results expected in the second quarter of 2019. The results will be used to help better define the planned U.S. Phase 3 cytisine clinical development program.
“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 Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences. “Smoking is responsible for the deaths of nearly a half a million Americans every year and new treatment options are desperately needed to help those battling nicotine addiction.”
Following the results from the Phase 2b optimization trial, the Company plans to initiate the Phase 3 program in 2019.