ACHV Achieve Life Sciences Inc.

9.39
-0.02  -0%
Previous Close 9.41
Open 9.38
52 Week Low 6.85
52 Week High 18.26
Market Cap $57,747,721
Shares 6,149,917
Float 6,132,083
Enterprise Value $22,186,718
Volume 35,107
Av. Daily Volume 73,135
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Drug Pipeline

Drug Stage Notes
Cytisine - ORCA-2
Smoking cessation
Phase 3
Phase 3
Phase 3 enrollment to be completed mid-2021.

Latest News

  1. SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / May 13, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced first quarter 2021 financial results and provided an update on the cytisinicline clinical development program.

    Recent Events & Highlights

    • Provided update on the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3.0 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 17 clinical sites in the United States
    • Published Phase 2b ORCA-1 safety, efficacy, and compliance results in Nicotine and Tobacco Research
    • Announced the appointment…

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / May 13, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced first quarter 2021 financial results and provided an update on the cytisinicline clinical development program.

    Recent Events & Highlights

    • Provided update on the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3.0 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 17 clinical sites in the United States
    • Published Phase 2b ORCA-1 safety, efficacy, and compliance results in Nicotine and Tobacco Research
    • Announced the appointment of Dr. Bridget Martell and Dr. Cindy Jacobs to Achieve's Board of Directors
    • Published RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix® (varenicline) in Addiction

    "In the first quarter, we've seen great interest and increased momentum in the ORCA-2 trial and look forward to completing enrollment by the middle of the year," commented John Bencich, Chief Executive Officer of Achieve. "We will continue to focus our efforts on execution of the Phase 3, ensuring all required NDA-enabling activities remain on track, and furthering our discussions with potential strategic partners to prepare for cytisinicline commercialization."

    Phase 3 ORCA-2 Trial
    The Phase 3 ORCA-2 trial continues to enroll at 17 clinical sites in the United States. Approximately 750 adult smokers will be randomized to one of three study arms to determine the efficacy and safety of cytisinicline administered for either six or twelve weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment in the six and twelve-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. The trial is expected to complete enrollment by the middle of 2021.

    ORCA-1 Results Published in Nicotine and Tobacco Research
    Results from the Phase 2b ORCA-1 trial were published in the scientific journal Nicotine and Tobacco Research. ORCA-1 evaluated the efficacy and safety of cytisinicline across various dosing and administration schedules in 254 smokers in the United States. The publication reported that subjects treated with cytisinicline, regardless of dose or schedule, had statistically significantly higher (p<0.001) end of treatment abstinence rates compared to those treated with placebo. Participants in the 3.0 mg cytisinicline 3 times daily (TID) arm, were five times more likely to quit smoking than those in the placebo arm (OR of 5.04, 95% CI: 1.42, 22.32, p<0.001). Cytisinicline was well-tolerated with no serious or severe adverse events (AEs) reported.

    Appointment of Drs. Martell and Jacobs to Board of Directors
    Achieve announced the appointment of two new members to Achieve's Board of Directors, Dr. Bridget Martell and Dr. Cindy Jacobs. Dr. Martell is board certified in both Internal and Addiction Medicine and is an experienced executive leader in the pharmaceutical industry. Dr. Jacobs serves as Achieve's President and Chief Medical Officer, and in addition to her Board of Directors duties, will continue in her current role leading Achieve's regulatory and clinical development efforts for cytisinicline.

    RAUORA Trial Results Published in Addiction
    Results from the Phase 3 RAUORA trial were published in the scientific journal Addiction. RAUORA evaluated the effectiveness and safety of cytisinicline compared to Chantix® (varenicline) as a smoking cessation aid in 679 indigenous New Zealanders (Māori). The published results indicate that cytisinicline met the pre-specified non-inferiority endpoint, and was trending towards superiority with an Absolute Risk Difference of +4.29 in favor of cytisinicline (95% CI -0.22 to 8.79), and a 55% improvement in quit rates at six months in favor of cytisinicline when compared to Chantix. A Bayesian analysis of the primary efficacy outcome is ongoing. Additionally, statistically significant fewer overall AEs were reported in cytisinicline-treated subjects (Relative Risk 0.56, 95% CI 0.49 to 0.65, p<0.001) including a significantly lower rate of nausea when compared to subjects on Chantix.

    Financial Results
    As of March 31, 2021, the company's cash, cash equivalents, and restricted cash was $29.7 million. Total operating expenses for the three months ended March 31, 2021 was $8.0 million. Total net loss for the three months ended March 31, 2021 was $8.0 million.

    As of May 13, 2021, Achieve had 6,164,360 shares outstanding.

    Conference Call Details
    Achieve will host a conference call at 4:30 pm Eastern time today, Thursday, May 13, 2021. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6096445. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

    About Achieve and Cytisinicline
    Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2 Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States.

    Forward-Looking Statements
    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 cytisinicline clinical development and commercialization activities, the potential market size for cytisinicline, the potential benefits of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these 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 others, the risk that cytisinicline may not demonstrate the hypothesized 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 commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve's intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of the COVID-19 pandemic or similar public health crises and the other factors described in the risk factors set forth in Achieve's filings with the Securities and Exchange Commission from time to time, including Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable.

    Media Contact
    Glenn Silver

    (646) 871-8485

    Investor Relations Contact
    Jason Wong

    (415) 375-3340 ext. 4

    References

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.

    2 U.S. Department of Health and Human Services. The Health Consequences of Smoking - 50 Years of Progress. A Report of the Surgeon General, 2014.

    Chantix® is a registered trademark of Pfizer, Inc.

    Consolidated Statements of Loss
    (In thousands, except per share and share data

    Three months ended March 31,
    2021 2020
    Operating expenses:
    Research and development
    5,642 1,541
    General and administrative
    2,342 1,816
    Total operating expenses
    7,984 3,357
    Loss from operations
    (7,984) (3,357)
    Other income (expense)
    (15) 37
    Net loss
    $(7,999) $(3,320)
    Basic and diluted net loss per share
    $(1.30) $(2.15)
    Weighted average number of basic and diluted common shares
    6,131,821 1,546,839

    Consolidated Balance Sheets
    (In thousands)

    March 31, December 31,
    2021 2020
    Assets:
    Cash and cash equivalents
    $ 29,637 $ 35,853
    Prepaid expenses and other current assets
    802 1,122
    Property, equipment, other assets and restricted cash
    272 279
    Right-of-use assets
    108 146
    License agreement
    1,809 1,864
    Goodwill
    1,034 1,034
    Total assets
    $ 33,662 $ 40,298
    Liabilities and stockholders' equity:
    Accounts payable and accrued liabilities
    $ 3,448 $ 2,843
    Current portion of long-term obligations
    67 92
    Long-term obligations
    59 77
    Stockholders' equity
    30,088 37,286
    Total liabilities and stockholders' equity
    $ 33,662 $ 40,298

    SOURCE: Achieve Life Sciences, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/647113/Achieve-Reports-Financial-Results-for-First-Quarter-2021-and-Provides-Corporate-Update

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  2. SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / May 4, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that it will report its first quarter 2021 financial results and provide an update on the cytisinicline development program on Thursday, May 13, 2021 at 4:30PM EDT.

    To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6096445…

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / May 4, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that it will report its first quarter 2021 financial results and provide an update on the cytisinicline development program on Thursday, May 13, 2021 at 4:30PM EDT.

    To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6096445. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

    Investor Relations Contact:
    Jason Wong

    (415) 375-3340 ext. 4

    Media Contact:

    Glenn Silver

    (646) 871-8485

    SOURCE: Achieve Life Sciences, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/642534/Achieve-Life-Sciences-to-Announce-First-Quarter-2021-Financial-Results-and-Host-Conference-Call-and-Webcast-on-May-13-2021

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  3. SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / April 22, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced it will be hosting a Virtual Non-Deal Roadshow on Tuesday, April 27, 2021, at 9:00AM EDT. Achieve's Chief Executive Officer, John Bencich, will be providing a corporate presentation and participating in a Q&A session with John Vandermosten, Senior Biotech Analyst at Zacks Small Cap Research.

    To access the presentation, please visit https://www.issuerdirect.com/snn/ndr/achieve-life-sciences.

    About Achieve and Cytisinicline
    Tobacco use is currently the leading cause of…

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / April 22, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced it will be hosting a Virtual Non-Deal Roadshow on Tuesday, April 27, 2021, at 9:00AM EDT. Achieve's Chief Executive Officer, John Bencich, will be providing a corporate presentation and participating in a Q&A session with John Vandermosten, Senior Biotech Analyst at Zacks Small Cap Research.

    To access the presentation, please visit https://www.issuerdirect.com/snn/ndr/achieve-life-sciences.

    About Achieve and Cytisinicline
    Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the U.S. annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction, and has not been approved by the FDA for any indication in the U.S. Achieve is currently enrolling smokers in the 750-subject, Phase 3 ORCA-2 study of cytisinicline at 16 sites in the U.S. For more information on cytisinicline and the ORCA-2 study, visit www.achievelifesciences.com or www.orca-2.com.

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    SNN.Network is your multimedia financial news platform for discovery, transparency, and due diligence. This is your one-stop hub to find new investment ideas, check in on watchlist, gather the most up-to-date information on the Small-, Micro-, Nano-Cap market with the goal to help you towards achieving your wealth generation goals. Follow the companies YOU want to know more about; read and watch content from YOUR favorite finance and investing influencers; create YOUR own watchlist and screen for ideas YOU'RE interested in; find out about investor conferences YOU want to attend - all here on SNN.Network.

    Forward Looking Statements

    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 cytisinicline clinical development activities, the potential market size and market acceptance for cytisinicline, the potential benefits of cytisinicline and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these 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 others, the risk that cytisinicline may not demonstrate the hypothesized 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 commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve's intellectual property may not be adequately protected; general business and economic conditions; and the other factors described in the risk factors set forth in Achieve's filings with the Securities and Exchange Commission from time to time, including Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

    Media Contact

    Glenn Silver

    (646) 871-8485

    Investor Relations Contact
    Jason Wong

    (415) 375-3340 ext. 4

    References

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
    2 U.S. Department of Health and Human Services. The Health Consequences of Smoking - 50 Years of Progress. A Report of the Surgeon General, 2014.

    SOURCE: Achieve Life Sciences, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/640488/Achieve-Life-Sciences-Inc-to-Host-Virtual-Non-Deal-Roadshow-on-Tuesday-April-27-2021

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  4. Cytisinicline Up to Five Times More Likely to Result in Smoking Abstinence Compared to Placebo

    Phase 3 ORCA-2 Trial Currently Enrolling at 16 sites in United States

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / April 14, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced publication of the results from the Phase 2b ORCA-1 trial in the scientific journal Nicotine and Tobacco Research.

    ORCA-1 evaluated the efficacy and safety of cytisinicline across various dosing and administration schedules in 254 smokers in the United States. The published results indicate that subjects…

    Cytisinicline Up to Five Times More Likely to Result in Smoking Abstinence Compared to Placebo

    Phase 3 ORCA-2 Trial Currently Enrolling at 16 sites in United States

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / April 14, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced publication of the results from the Phase 2b ORCA-1 trial in the scientific journal Nicotine and Tobacco Research.

    ORCA-1 evaluated the efficacy and safety of cytisinicline across various dosing and administration schedules in 254 smokers in the United States. The published results indicate that subjects treated with cytisinicline, regardless of dose or schedule, had statistically significantly higher (p<0.001) end of treatment abstinence rates compared to those treated with placebo. Participants in the 3.0 mg cytisinicline 3 times daily (TID) arm, were 5-times more likely to quit smoking than those in the placebo arm (OR of 5.04, 95% CI: 1.42, 22.32, p<0.001).

    Cytisinicline was well-tolerated with no serious or severe adverse events (AEs) reported. Overall, in subjects treated with cytisinicline, all individual AE's reported were below a rate of 10%. In the 3.0 mg TID treatment arm versus placebo, the most common AEs were abnormal dreams, insomnia, and constipation (each 6% vs 2%), upper respiratory tract infections (6% vs 14%), and nausea (6% vs 10%). Adherence to study treatment was greater than 94% across all treatment arms and 98% in the 3.0 mg TID arm, specifically.

    "As demonstrated in ORCA-1, cytisinicline is an efficacious and tolerable smoking cessation treatment that, when available, will be well-received by physicians and smokers who desperately need new cessation options," stated Dr. Mitch Nides, ORCA-1 Primary Investigator. "The ongoing Phase 3 ORCA-2 trial is enrolling rapidly, and I would encourage those who are interested in quitting and who are near a trial location to consider participating."

    Healthcare providers, smokers, and their loved ones can learn more about how smokers can participate in the Phase 3 ORCA-2 trial by visiting www.orca-2.com.

    About ORCA-1

    ORCA-1 was the first study in Achieve's ORCA (Ongoing Research of Cytisinicline for Addiction) Program, which aims to evaluate the safety and effectiveness of cytisinicline for smoking cessation, nicotine addiction, and potentially other indications. The study was designed to evaluate the declining titration schedule, currently utilized in Central and Eastern Europe, compared to a simplified TID schedule at both the 1.5 mg and 3.0 mg cytisinicline doses compared to placebo. ORCA-1 topline results were announced in June 2019 and enrolled 254 smokers at eight centers across the United States.

    To access the ORCA-1 publication, visit https://academic.oup.com/ntr/advance-article/doi/10.1093/ntr/ntab073/6224724?searchresult=1.

    About Achieve and Cytisinicline
    Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the U.S. annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction, and has not been approved by the FDA for any indication in the U.S. Achieve is currently enrolling smokers in the 750-subject, Phase 3 ORCA-2 study of cytisinicline at 16 sites in the U.S. For more information on cytisinicline and the ORCA-2 study, visit www.achievelifesciences.com or www.orca-2.com.

    Forward Looking Statements

    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 cytisinicline clinical development activities, the potential market size and market acceptance for cytisinicline, the potential benefits of cytisinicline and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these 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 others, the risk that cytisinicline may not demonstrate the hypothesized 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 commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve's intellectual property may not be adequately protected; general business and economic conditions; and the other factors described in the risk factors set forth in Achieve's filings with the Securities and Exchange Commission from time to time, including Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

    Media Contact:
    Glenn Silver

    (646) 871-8485

    Investor Relations Contact:
    Jason Wong

    (415) 375-3340 ext. 4

    References

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.

    2 U.S. Department of Health and Human Services. The Health Consequences of Smoking - 50 Years of Progress. A Report of the Surgeon General, 2014.

    SOURCE: Achieve Life Sciences, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/639363/Achieve-Announces-Publication-of-the-ORCA-1-Phase-2b-Clinical-Trial-of-Cytisinicline-in-Adult-Smokers-in-Nicotine-and-Tobacco-Research

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  5. Subjects treated with cytisinicline were 55% more likely to quit smoking at 6 months and experienced significantly fewer side effects compared to those who received varenicline

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 25, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced online publication of the results from the Phase 3 RAUORA trial in the scientific journal Addiction. The RAUORA study was led by Dr. Natalie Walker, Associate Professor at the University of Auckland, and evaluated the effectiveness and safety of cytisinicline compared to varenicline (Chantix®…

    Subjects treated with cytisinicline were 55% more likely to quit smoking at 6 months and experienced significantly fewer side effects compared to those who received varenicline

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 25, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced online publication of the results from the Phase 3 RAUORA trial in the scientific journal Addiction. The RAUORA study was led by Dr. Natalie Walker, Associate Professor at the University of Auckland, and evaluated the effectiveness and safety of cytisinicline compared to varenicline (Chantix®) as a smoking cessation aid in 679 indigenous New Zealanders (Māori) or their extended family.

    The published results indicate that cytisinicline met the pre-specified non-inferiority endpoint, and was trending towards superiority with an Absolute Risk Difference of +4.29 in favor of cytisinicline (95% CI -0.22 to 8.79), and a 55% improvement in quit rates at six months in favor of cytisinicline when compared to varenicline. A Bayesian analysis of the primary efficacy outcome is ongoing.

    Additionally, statistically significant fewer overall adverse events (AEs) were reported in cytisinicline-treated subjects (Relative Risk 0.56, 95% CI 0.49 to 0.65, p<0.001) including a significantly lower rate of nausea when compared to subjects on varenicline. Notably, as participants were not blinded to study drug, more subjects refused to participate and withdrew consent when randomized to varenicline compared to subjects who were randomized to cytisinicline.

    "These data add to the growing body of evidence in support of cytisinicline as a much-needed, potential new treatment alternative to existing smoking cessation therapies," said John Bencich, Chief Executive Officer of Achieve Life Sciences. "Many smokers refuse to take current medications or stop treatment when they experience side effects which impedes their ability to quit successfully. We believe the tolerability profile of cytisinicline, as shown in trials such as RAUORA, may help smokers remain on treatment and lead to better outcomes for those battling nicotine addiction."

    To access the RAUORA publication, visit https://onlinelibrary.wiley.com/doi/10.1111/add.15489.

    Achieve is currently enrolling smokers in the 750-subject, Phase 3 ORCA-2 study of cytisinicline at 15 sites in the U.S. For more information on cytisinicline and the ORCA-2 study, visit www.achievelifesciences.com or www.orca-2.com.

    About the RAUORA Study

    The RAUORA study was conducted by the researchers at the University of Auckland, in conjunction with the Health Economics Research Group (HERG) at Brunel University London, and Lakes District Health Board. Currently, 3 in 10 Māori smoke, three times more than non-Māori, and supporting this population to quit smoking is a priority of the New Zealand government. The study compared cytisinicline administered on a schedule of 25 days of downward dosing titration followed by twice-daily dosing for a total of 12 weeks with varenicline administered on a schedule of 7 days of upward titration followed by twice-daily dosing for a total of 12 weeks. The primary endpoint was continuous abstinence from smoking for 6 months post-quit date.

    In total, 1,105 Māori or whānau (Māori extended family members) expressed interest in participating in the study and a total of 679 were randomized to receive either cytisinicline or varenicline. The average age of participants in the trial was 43 years and approximately 70% of the participants were women. Contact was sought over a period of six to 12 months to collect data and support their quit journey.

    About Achieve and Cytisinicline
    Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the U.S. annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction, and has not been approved by the FDA for any indication in the U.S.

    Forward-Looking Statements

    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 cytisinicline clinical development activities, the potential market size and market acceptance for cytisinicline, the potential benefits of cytisinicline and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these 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 others, the risk that cytisinicline may not demonstrate the hypothesized 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 commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve's intellectual property may not be adequately protected; general business and economic conditions; and the other factors described in the risk factors set forth in Achieve's filings with the Securities and Exchange Commission from time to time, including Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

    Media Contact
    Glenn Silver

    (646) 871-8485

    Investor Relations Contact
    Jason Wong

    (415) 375-3340 ext. 4

    References

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
    2 U.S. Department of Health and Human Services. The Health Consequences of Smoking - 50 Years of Progress. A Report of the Surgeon General, 2014.

    Chantix® is a registered trademark of Pfizer Inc.

    SOURCE: Achieve Life Sciences, Inc.



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