ACHV - Achieve Life stock rises 10% as cytisinicline helps quit smoking in phase 3 trial

2023-05-23 07:05:48 ET

Achieve Life Sciences ( NASDAQ: ACHV ) said cytisinicline showed a statistically significant benefit in helping people quit smoking compared to placebo, with low rates of adverse events in a second, confirmatory phase 3 trial.

The study, dubbed ORCA-3, evaluated 3mg cytisinicline dosed 3 times daily for 6 or 12 weeks, compared to placebo and enrolled 792 adult smokers at 20 trial sites in the U.S. All participants received standard behavioral support during the study.

The main goal of the trial was smoking cessation measured during the last 4 weeks of treatment.

ACHV said the 6 and 12 weeks of cytisinicline therapy period showed statistically significant smoking cessation on the main and secondary efficacy analyses, compared to placebo.

Cytisinicline 12-week :

People who received cytisinicline for 12 weeks had 4.4 times higher likelihood to have quit smoking during the last 4 weeks of treatment, compared to those on placebo. The smoking cessation rate during weeks 9 to 12 was 30.3% for cytisinicline versus 9.4% for placebo, accrong to the company.

On the secondary goal, the continuous smoking cessation rate from week 9 to week 24 was 20.5% for the 12-week cytisinicline group versus 4.2% for placebo, with an odds ratio of 5.79, ACHV added.

Cytisinicline 6-week :

The company said people on cytisinicline for six weeks had 2.85 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment versus those on placebo.

On the secondary objective, the continuous smoking cessation rate from week 3 to week 24 was 6.8% for the 6-week cytisinicline group compared to 1.1% for placebo, with an odds ratio of 6.25

Safety Data :

ACHV said that similar to data from its ORCA-2 study, cytisinicline was well-tolerated with no treatment-related serious adverse events.

The most common (>5% overall) adverse events for placebo, 6-week cytisinicline, and 12-week cytisinicline were — Insomnia 7.6%, 11.0%, and 11.9%. Abnormal dreams: (5.7%, 9.1%, 7.7%).

"We are excited about the future and continuing our work with regulators with the aim of bringing cytisinicline to market," said Achieve Life Sciences' CEO John Bencich.

In ORCA-3, participants had an average age of 53 years, and smoked a median of 20 cigarettes per day at baseline.

ACHV +10.06% to $8.97 premarket May 23

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