ACHV: Topline Data from ORCA-2 Smoking Cessation Trial

By John Vandermosten, CFA

NASDAQ:ACHV

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Achieve Life Sciences, Inc. ACHV reported topline data from its Phase III Ongoing Research of Cytisinicline for Addiction (ORCA)-2 trial. The press release was released on April 27, 2022 and was accompanied by a webcast and side deck.

Topline data was impressive with the primary endpoint of biochemically verified continuous abstinence measured during the last four weeks of treatment between a cytisinicline arm of either twelve or six weeks and a placebo arm. We summarize the data below showing the cytisinicline arm with a result 20 points higher for a six-week and a 26 points higher for a twelve-week dosing period vs. placebo:

For the secondary endpoint of continuous abstinence during the last three weeks of treatment to 24 weeks, we provide summarized results below. Results show a 6.3 percentage point improvement for the six-week group and a 16.3 percentage point improvement for the twelve-week group.

p-values for the primary and secondary endpoints were significant, all falling substantially below the 1% hurdle.

The side effect profile, which we have publicized as one of the stronger arguments for cytisinicline over competing products was also spectacular. Headaches and nausea were both lower for the cytisinicline arms compared with the placebo arm. This is in contrast to data provided for varenicline in its FDA label which was substantially greater for the active arm vs. the placebo arm.³

ORCA-2 was a Phase III clinical trial that enrolled 810 adult smokers to evaluate the efficacy and safety of cytisinicline as a treatment for smoking cessation. Participants were randomized into three treatment arms to receive either placebo or 3 mg cytisinicline taken three times daily for a period of either 6 or 12 weeks. The primary endpoints for ORCA-2 were biochemically verified continuous abstinence measured during the last 4 weeks of treatment. Secondary endpoints measured continuous abstinence after treatment up to 24 weeks. Subjects were monitored for smoking abstinence for 24 weeks post randomization and received standard behavioral support for the duration of the trial. ORCA-2 participants were an average age of 54 years, smoked on average 20 cigarettes per day at baseline, and had a median smoking history of 38 years with 4 prior quit attempts.

In our opinion, results were very strong and show the benefit of increasing the dosage of cytisinicline and duration of treatment relative to the upwardly titrating approach that had been previously used. The results exceed our expectations in terms of efficacy and safety and bode well for the confirmatory ORCA-3 trial which is now underway.

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1. Source: Zacks analyst compiled exhibit using data provided by Achieve Life Sciences

2. Source: Zacks analyst compiled exhibit using data provided by Achieve Life Sciences

3. According to the FDA label for varenicline, nausea was reported in 16% of the 0.5 mg group, 30% in the 1 mg group and only 10% in the placebo group. Headache was 19% in the 0.5 mg group, 18% in the 1 mg group and 13% in the placebo group. Since the trials were structured differently, direct comparisons are difficult; however, directionally the results suggest that cytisinicline has a better profile for nausea and headache. For insomnia and abnormal dreams, both cytisinicline and varenicline arms showed higher incidence as compared to the placebo arm.

4. Source: Zacks analyst compiled exhibit using data provided by Achieve Life Sciences

5. Source: Achieve Life Sciences Clinical Development Update Corporate Presentation April 2022

6. Source: Achieve Life Sciences Clinical Development Update Corporate Presentation April 2022