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Achieve Life Sciences Announces Initiation of Phase 2 ORCA-V1 Clinical Trial Evaluating Cytisinicline for Nicotine e-cigarette Cessation
SEATTLE and VANCOUVER, British Columbia, June 29, 2022 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"SEATTLE and VANCOUVER, British Columbia, June 29, 2022 (GLOBE NEWSWIRE) -- 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 addiction, today announced it has initiated screening of subjects for the ORCA-V1 Phase 2 clinical trial. ORCA-V1 will evaluate the efficacy and safety of 3mg cytisinicline dosed 3 times daily compared to placebo in approximately 150 adult e-cigarette users at 5 clinical trial locations in the United States. Participants will be randomized to receive cytisinicline or placebo for 12 weeks in combination with standard cessation behavioral support. ORCA-V1 is being supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) through grant funding which was awarded in two phases totaling $2.8 million. During the first phase, Achieve’s Investigational New Drug application for nicotine e-cigarette cessation was reviewed and accepted by the U.S. Food and Drug Administration (FDA) late last year. “The initiation of the ORCA-V1 trial of cytisinicline in e-cigarette users is yet another example of honoring our commitment to deliver on key milestones and our dedication to helping the millions of people who desire to overcome their addiction to nicotine,” stated John Bencich, Chief Executive Officer of Achieve. “We are appreciative of the partnership with NIDA and NIH that is enabling this important research to be conducted and to our clinical trial sites who are eager to begin enrolling participants.” In addition to the initiated ORCA-V1 trial, Achieve is evaluating smoking cessation of combustible cigarettes in its Phase 3 clinical development program. The ORCA-2 clinical trial, which was comprised of 810 adult smokers, announced positive topline results in April. Smokers who received cytisinicline in ORCA-2 were up to 8 times more likely to have quit smoking compared to those who received placebo. The ORCA-3 trial, the intended confirmatory Phase 3 trial required for regulatory submission of cytisinicline, is currently enrolling smokers at 15 clinical trial locations in the United States. For additional information on Achieve or the cytisinicline development program, visit achievelifesciences.com or orcaprogram.com. The planned research an...