Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company developing and commercializing cytisinicline for smoking cessation, presented three posters on February 25, 2021 at the Society for Research on Nicotine & Tobacco (SRNT) Annual Meeting, held virtually this year. The three posters featured survey data on smoker and e-cigarette user behavior.
The posters were entitled:
Dr. Anthony Clarke, Chief Scientific Officer for Achieve, presented data from Achieve’s 15 minute online survey in adults aged 19-64 who were current daily smokers or smokers who had quit in the past year. Enrollment in the survey targeted 1,000 respondents over the two week period, August 27 through September 3, 2019. An honorarium of $9.00 was paid for completing the survey. In total, 1,122 current and former smokers participated in the survey with 986 current smokers and 136 recent quitters. All participants had also used an FDA-approved prescription pill (varenicline or bupropion) and/or nicotine replacement therapy at least once in a prior quit attempt.
Exhibit I – Medications Used to Quit (1)
Of those that attempted to quit using a prescription pill, the full 12-week course was not completed in a majority of cases. 53% completed less than one month of therapy, with about half of those completing three weeks or less.
Exhibit II – Compliance to Prescription Cessation Treatment (3)
Side effects were reported (61%) as a key reason for non-compliance. In those who had not used a prescription pill, fear of side effects was reported by 49% of responders. Lack of efficacy was reported by 27% of prescription and 42% of non prescription attempted quitters. The results indicated that the satisfaction and perceived efficacy of available cessation treatments was low. Less than a third of respondents who attempted to quit using prescription pills reported perceived efficacy and satisfaction. E-cigarettes were comparable in efficacy, trending superior, although as revealed by Achieve’s other survey in vape users, e-cigarettes are not effective in addressing the underlying nicotine addiction.
Exhibit III – Perceived Effectiveness and Satisfaction with Cessation Available Treatments (3)
In addition to the data from the aforementioned survey in smokers, Dr. Anthony Clarke also presented data from another survey regarding vape user behavior and quit intentions. This survey was also 15 minutes in duration, targeting adult respondents between the ages of 19 and 64, who vaped daily. A total of 500 respondents were targeted over two weeks and an honorarium of $9.00 was paid for completing the survey. 508 individuals completed the survey between February 29 and March 12, 2020. The population included 249 past smokers, 247 dual users, and 12 never smokers. Data from never smokers was not presented. Dr. Clarke discussed the survey data relating to the reason that people started to vape.
Exhibit IV – Reasons to Start Vaping (4)
81% of past smokers and 62% of dual users reported that they begin vaping to quit smoking. Social factors had an influence as well. Respondents reported a reduction in cigarette smoking upon initiation of vaping in both groups with 85% of past smokers and 59% of dual users identifying this result. Of the dual users that had quit smoking due to vaping, ~56% began smoking again within three months. Dual users reported using vape pods and e-cigarettes twice that of past smokers and vaped in locations where smoking was not permitted. The PH-294 poster presented these results.
Dr. Clarke then proceeded to explain that a quarter of vapers planned to quit vaping in the next three months, a third in the next three to six months, and 43% in the next 12 months. Almost three quarters of dual users expressed interest in a new prescription treatment to help them quit, which supports broad acceptance of cytisinicline if approved. Finally, 84% of dual users and 50% of past smokers consulted their primary care physician for advice on cessation, identifying an important target group for cytisinicline’s commercialization efforts. These results were covered in the PH-295 poster.
Exhibit V – Quitting Intentions of Vape/E-cigarette Users (5)
In the press release announcing the presentations and posters at SRNT, John Bencich, Achieve’s CEO, commented that the combined evidence indicated the substantial need for a new therapeutic option for smokers who largely wish to quit but face the side effects of current standard of care. Bencich reminded investors that Achieve’s lead candidate, cytisinicline has demonstrated a favorable tolerability profile and a lack of common side effects which may help smokers adhere to treatment and overcome their addiction.
ORCA-2 Phase III Trial
Achieve’s lead candidate, cytisinicline, is currently enrolling in its Phase III trial. Achieve announced the start of its Phase III ORCA-2 trial on October 7th which is targeting enrollment of 750 smokers across 15 clinical sites throughout the United States. The trial is a multi-center, double-blind, randomized, placebo-controlled Phase III study that is enrolling adult cigarette smokers who intend to quit smoking. Subjects will be randomized into one of three arms which include 12 weeks of placebo, six weeks of cytisinicline then six weeks of placebo and 12 weeks of cytisinicline. Dosing will be 3.0 mg, three times daily in each of the treatment cohorts. Management anticipates enrollment to be complete by the end of the first quarter 2021.
Exhibit VI – ORCA-2 Phase III Trial Design (6)
The primary endpoints for the ORCA-2 study will be the rate of smoking abstinence at the end of 6- and 12-week treatment periods compared to placebo. Abstinence will be defined as no smoking during the last four weeks of treatment using weekly CO biochemical verification. Secondary endpoints will be based upon continued smoking abstinence until week 24 from the end of treatment and identify a reduction in the risk of relapse for subjects on the 6 week treatment regimen compared to the 12 week. Efforts have been made to prepare sites to comply with COVID-19 restrictions. The trial has now begun enrollment, which is expected to be supported by New Year’s resolutions to quit smoking.
In summary, the results from Achieve’s survey work, presented at the most recent SRNT Annual Meeting, indicate that current prescription pills and nicotine replacement therapy are ineffective or unsatisfactory for a majority of attempted quitters. Electronic cigarettes are comparably effective to prescription pills, but they present their own risks, with dual users consuming double the nicotine than before by both smoking and vaping. Thus, there is a significant and unmet need in the smoking/vaping population that cytisinicline, with its favorable lack of side effects, can potentially address. Achieve’s cytisinicline is currently in Phase III evaluation (ORCA-2). Enrollment is currently underway, targeting 750 subjects in 15 sites across the US.
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1. A Survey in the United States of Attitudes to Nicotine Cessation in Smokers: Smokers; Satisfaction with Available Treatments. Clarke, Xinos, Stewart. Achieve Life Sciences – SRNT 2021
2. A Survey in the United States of Attitudes to Nicotine Cessation in Smokers: Smokers; Satisfaction with Available Treatments. Clarke, Xinos, Stewart. Achieve Life Sciences – SRNT 2021
3. A Survey in the United States of Attitudes to Nicotine Cessation in Smokers: Smokers; Satisfaction with Available Treatments. Clarke, Xinos, Stewart. Achieve Life Sciences – SRNT 2021
4. A Survey in the United States of Attitudes to Nicotine Cessation in Vapers: Reasons for Choosing to Vape, Clarke, Xinos, Stewart, Achieve Life Sciences – SRNT 2021
5. A Survey in the United States of Attitudes to Nicotine Cessation in Vapers: Their Plans to Quit Vaping, Clarke, Xinos, Stewart, Achieve Life Sciences – SRNT 2021
6. Source: Achieve Life Sciences S-1 Filed November 6, 2019.