Achieve Life Sciences Announces Initiation of ORCA-V1 Phase 2 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 engaged in the development and global commercialization of cytisinicline for Smoking Cessation and Nicotine Dependence, today announced that it has initiated subject screening for the ORCA-V1 Phase 2 clinical trial.
ORCA-V1 will evaluate the efficacy and safety of 3 mg of cytisinicline given 3 times daily versus placebo in approximately 150 adult e-cigarette users at 5 clinical trial sites in the United States. Participants will be randomized to receive cytisinicline or placebo for 12 weeks in combination with standard withdrawal behavioral support. ORCA-V1 is supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) through a grant that was awarded in two phases for a total of $2.8 million. During the first phase, Achieve’s investigational new drug application for nicotine e-cigarette cessation was reviewed and accepted by the United States Food and Drug Administration (FDA) at the end of the first phase. ‘last year.
“The launch of the ORCA-V1 trial of cytisinicline in e-cigarette users is another example of our fulfillment of our commitment to milestones and our dedication to helping the millions of people who want to overcome their addiction to e-cigarettes. nicotine,” said John Bencich, CEO of Achieve. “We appreciate the partnership with NIDA and NIH that allows this important research to be conducted and our clinical trial sites that are eager to begin recruiting participants.”
In addition to the launched ORCA-V1 trial, Achieve is evaluating the smoking cessation of combustible cigarettes in its Phase 3 clinical development program. The ORCA-2 clinical trial, which included 810 adult smokers, has announced positive results in April. Smokers who received cytisinicline in ORCA-2 were up to 8 times more likely to have quit smoking than those who received a placebo. The ORCA-3 trial, the planned confirmatory Phase 3 trial required for regulatory submission of cytisinicline, is currently enrolling smokers at 15 clinical trial sites in the United States. For more information about Achieve or the Cytisinicline Development Program, visit reallifesciences.com Where orcaprogram.com.
The planned research and clinical study described in this press release is supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) under award number 4R44DA054784-02. The content is the sole responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About Achieve and Cytisinicline
Achieve’s goal is to combat the global epidemic of tobacco use and nicotine addiction through the development and commercialization of cytisinicline. Smoking is currently the leading cause of preventable death, responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States each year.1.2 More than 87% of lung cancer deaths, 61% of all lung disease deaths, and 32% of all coronary heart disease deaths are attributable to smoking and exposure to second-hand smoke.2
Additionally, nearly 11 million adults in the United States use e-cigarettes, also known as vaping.3 Although nicotine e-cigarettes are considered less harmful than combustible cigarettes, they are still addictive and can release harmful chemicals that can cause lung damage or cardiovascular disease.4 In 2021, e-cigarettes were the most commonly used tobacco product reported by 1.72 million high school students.5 Research shows that teens who have used e-cigarettes are seven times more likely to become smokers a year later than those who have never vaped.6 Currently, there are no FDA-approved treatments indicated specifically as an aid in quitting nicotine e-cigarettes.
Cytisinicline is a plant-derived alkaloid with high binding affinity to the nicotinic acetylcholine receptor. It is believed to help treat nicotine dependence for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms and reducing reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate under development for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve, visit www.achievelifesciences.com.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of development cytisinicline clinical, data results and marketing. activities, the potential size of the cytisinicline market, the potential benefits, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including, but not limited to, in as an e-cigarette cessation product, the development and effectiveness of new treatments, and the intention to submit cytisinicline to the FDA for approval. All statements other than statements of historical fact are statements that could be considered forward-looking statements. Achieve may not achieve its product development plans or objectives in a timely manner, if at all, or otherwise achieve its intentions or meet its expectations or projections disclosed in such forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among other things, the risk that cytisinicline may not demonstrate hypothetical or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully marketed; the risk that new developments in the smoking cessation landscape may require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general commercial and economic conditions; the risks related to the impact on our activities of Russian military action in Ukraine; risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises and other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time other, including Achieve’s annual reports on Form 10-K and quarterly reports on Form 10-Q. Achieve undertakes no obligation to update any forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, except as may be required by applicable.
1 World Health Organization. WHO report on the global tobacco epidemic, 2019. Geneva: World Health Organization, 2017.
2 US Department of Health and Human Services. The health consequences of smoking – 50 years of progress. A report of the Surgeon General, 2014.
3 Cornelius ME, Wang TW, Jamal A, Loretan CG, Neff LJ. Use of tobacco products among adults — United States, 2019. MMWR Morb Mortal Wkly Rep 2020;69:1736–1742. DOI: 10.15585/mmwr.mm6946a4
4 Ogunwale, Mumiye A et al. (2017) Aldehyde detection in e-cigarette aerosols. ACS omega 2(3): 1207-1214. DOI: 10.1021/acsomega.6b00489].
5 Gentzke AS, Wang TW, Cornelius M, et al. Tobacco product use and associated factors among middle and high school students – National Youth Smoking Survey, United States, 2021. MMWR Surveill Summ 2022;71(#SS-5):1-29. DOI: 10.15585/mmwr.ss7105a1.
6 Elizabeth C. Hair, Alexis A. Barton, Siobhan N. Perks, Jennifer Kreslake, Haijun Xiao, Lindsay Pitzer, Adam M. Leventhal, Donna M. Vallone, Association between e-cigarette use and future cigarette use combustibles: evidence from a prospective cohort study of youth and young adults, 2017-2019, Addictive Behaviors, Volume 112, 2021, 106593, ISSN 0306-4603. DOI: 10.1016/j.addbeh.2020.106593.