- Achieve Life Sciences Inc ACHV reported topline results from its Phase 2 ORCA-V1 trial evaluating 3mg cytisinicline dosed three times daily for 12 weeks compared to placebo in 160 adults who use e-cigarettes or nicotine vapes and who do not currently smoke cigarettes.
- Subjects who received 12 weeks of cytisinicline treatment had 2.6 times higher odds, or likelihood, to have quit vaping during the last four weeks of treatment compared to subjects who received a placebo (p=0.035).
- The vaping cessation rate during weeks 9-12 was 31.8% for cytisinicline compared to 15.1% for placebo. A benefit in favor of cytisinicline was consistently observed across the secondary endpoints.
- Additionally, a cessation benefit was observed for cytisinicline across clinical trial sites and participant demographics.
- Cytisinicline was well tolerated, and no serious adverse events were reported. Similar adverse events (AE's) rates were observed between treatment arms (54.7% in the placebo arm vs. 50.9% in the cytisinicline arm).
- In addition to the results of this study, Achieve Life Sciences plans to announce topline results in Q3 2023 from the Phase 3 ORCA-3 trial for cytisinicline as a new smoking cessation treatment in people who want to quit daily cigarette smoking but have not been able to do so using other available treatments.
- Price Action: ACHV shares are down 2.71% at $6.74 on the last check Thursday.
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