Achieve Life Sciences reports positive topline results from the Phase 3 ORCA-3 trial of cytisinicline (POSITIVE)

25.05.2023 Source: Achieve Life Science; Sopharma; FFBH

“Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, announced positive topline results from the Phase 3 ORCA-3 trial of cytisinicline. Consistent with the previously reported Phase 3 ORCA-2 study, ORCA-3 showed a statistically significant benefit in helping people to quit smoking compared to placebo, with low rates of adverse events”, the company announced. ORCA-3 randomized 792 adult smokers who were dosed 3mg cytisinicline 3 times daily for a period of 6 weeks or 12 weeks compared to placebo. Both the 6- and 12-week treatment durations demonstrated statistically significant smoking cessation on both the primary and secondary efficacy analyses. Similar to ORCA-2 findings, cytisinicline was well-tolerated with no treatment-related serious adverse events reported. If approved, cytisinicline could be the first new prescription treatment in nearly 20 years to help the millions of smokers to overcome nicotine dependence. Note that Cytisinicline (Tabex) is an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe by Sopharma for over 20 years. Achieve has an exclusive license and supply agreement with Sopharma for the development and commercialization of cytisinicline outside of Sopharma’s territories. According to the license agreement, Achieve would pay royalty fees to Sopharma in the mid-single digits of all net sales of Tabex branded products until May 26, 2029, including those sold by a third party pursuant to any sublicense which may be granted by Achieve. The supply agreement stipulates that Achieve will exclusively purchase all cytisinicline from Sopharma until 2037.