Achieve Life Sciences to Advance First Vaping Cessation Therapy After Successful End-of-Phase 2 Meeting with FDA
Achieve Life Sciences (Nasdaq: ACHV) announced successful completion of its End-of-Phase 2 FDA meeting for cytisinicline as a potential first-in-class treatment for vaping cessation. The FDA agreed that one Phase 3 trial (ORCA-V2), along with the completed Phase 2 ORCA-V1 trial, would suffice for a vaping cessation indication. The planned Phase 3 study will evaluate 3 mg cytisinicline three times daily versus placebo in approximately 800 adults who use e-cigarettes. The trial is targeted to begin in Q3 2025, addressing an unmet need among 11 million U.S. adult vapers, of whom 60% want to quit.
Achieve Life Sciences (Nasdaq: ACHV) ha annunciato il completamento con successo del suo incontro End-of-Phase 2 con la FDA riguardante il cytisinicline come potenziale trattamento di prima classe per la cessazione del fumo di sigaretta elettronica. La FDA ha concordato che un trial di fase 3 (ORCA-V2), insieme al trial di fase 2 completato ORCA-V1, sarebbe sufficiente per un'indicazione di cessazione del fumo. Lo studio di fase 3 pianificato valuterà 3 mg di cytisinicline tre volte al giorno rispetto al placebo in circa 800 adulti che usano sigarette elettroniche. Il trial è previsto per iniziare nel terzo trimestre del 2025, rispondendo a un'esigenza insoddisfatta tra gli 11 milioni di adulti che svapano negli Stati Uniti, di cui il 60% desidera smettere.
Achieve Life Sciences (Nasdaq: ACHV) anunció la finalización exitosa de su reunión de Final de Fase 2 con la FDA sobre el cytisinicline como un posible tratamiento de primera clase para la cesación del vapeo. La FDA coincidió en que un ensayo de fase 3 (ORCA-V2), junto con el ensayo de fase 2 completado ORCA-V1, sería suficiente para una indicación de cesación del vapeo. El estudio de fase 3 planificado evaluará 3 mg de cytisinicline tres veces al día frente al placebo en aproximadamente 800 adultos que usan e-cigarrillos. Se espera que el ensayo comience en el tercer trimestre de 2025, atendiendo una necesidad no satisfecha entre 11 millones de adultos vapers en EE. UU., de los cuales el 60% desea dejar de fumar.
Achieve Life Sciences (Nasdaq: ACHV)는 전자담배 중단을 위한 잠재적인 첫 번째 클래스 치료제로서 cytisinicline의 2단계 FDA 회의 성공적인 완료를 발표했습니다. FDA는 완료된 2단계 시험인 ORCA-V1과 함께 Phase 3 시험(ORCA-V2) 하나로 전자담배 중단에 대한 적응증을 충분히 제공할 수 있다고 합의했습니다. 계획된 3단계 연구는 약 800명의 전자담배 사용자 성인에 대해 3mg의 cytisinicline을 하루 3회 투여하고 대조군과 비교할 것입니다. 이 시험은 2025년 3분기에 시작될 예정이며, 미국에서 1,100만 성인 전자담배 사용자 중 60%가 금연을 원하고 있는 미충족 수요에 대응할 것입니다.
Achieve Life Sciences (Nasdaq: ACHV) a annoncé le succès de sa réunion de fin de phase 2 avec la FDA concernant le cytisinicline en tant que traitement potentiel de première classe pour l'arrêt du vapotage. La FDA a convenu qu'un essai de phase 3 (ORCA-V2), ainsi que l'essai de phase 2 terminé ORCA-V1, suffiraient pour une indication d'arrêt du vapotage. L'étude de phase 3 prévue évaluera 3 mg de cytisinicline trois fois par jour par rapport à un placebo chez environ 800 adultes utilisant des e-cigarettes. L'essai est prévu pour débuter au troisième trimestre de 2025, répondant à un besoin non satisfait chez 11 millions de vapoteurs adultes aux États-Unis, dont 60 % souhaitent arrêter.
Achieve Life Sciences (Nasdaq: ACHV) hat den erfolgreichen Abschluss seines End-of-Phase-2-FDA-Treffens für Cytisiniclin als potenzielle Behandlung der ersten Klasse zur Beendigung des Dampfens bekannt gegeben. Die FDA stimmte zu, dass eine Phase-3-Studie (ORCA-V2) sowie die abgeschlossene Phase-2-Studie ORCA-V1 für eine Dampf-Stopp-Indikation ausreichen würden. Die geplante Phase-3-Studie wird 3 mg Cytisiniclin dreimal täglich im Vergleich zu einem Placebo bei etwa 800 Erwachsenen, die E-Zigaretten verwenden, evaluieren. Die Studie soll im dritten Quartal 2025 beginnen und damit einen ungedeckten Bedarf bei 11 Millionen US-Erwachsenen, die dampfen, decken, von denen 60% aufhören möchten.
- FDA agreement on single Phase 3 trial requirement streamlines approval pathway
- Breakthrough Therapy designation accelerates development timeline
- Large addressable market with 11 million adult vapers in the US
- No currently approved treatment for vaping cessation
- Successfully completed Phase 2 trial and two Phase 3 trials in smoking cessation
- Phase 3 trial not starting until Q3 2025
- Additional clinical trials required before potential approval
- NDA submission for smoking cessation delayed until Q2 2025
Insights
The FDA's agreement on a single Phase 3 trial (ORCA-V2) for cytisinicline in vaping cessation represents a significant regulatory milestone. The study design targeting 800 adults with previous failed quit attempts is robust and well-aligned with clinical requirements. The 12-week treatment duration with biochemical verification of abstinence follows established protocols, while the 24-week follow-up will provide important long-term efficacy data.
The FDA's Breakthrough Therapy designation and acceptance of a single Phase 3 trial, rather than the typical two trials, suggests strong confidence in cytisinicline's potential. With 11 million adult vapers in the US and no approved cessation treatments, cytisinicline could capture a substantial untapped market. The successful completion of two Phase 3 trials in smoking cessation with 1,600+ subjects provides additional safety data support.
This regulatory advancement positions Achieve Life Sciences favorably in the untapped vaping cessation market. With 60% of vapers wanting to quit and no FDA-approved treatments available, cytisinicline could become a first-mover in this space. The streamlined regulatory pathway through Breakthrough Therapy designation and single Phase 3 trial requirement accelerates time-to-market and reduces development costs.
The planned Q3 2025 initiation of ORCA-V2, combined with the anticipated Q2 2025 NDA submission for smoking cessation, creates multiple near-term catalysts. The company's focus on both smoking and vaping cessation broadens market potential and diversifies revenue streams. The targeting of young adult vapers (18-24 years) who have never smoked represents a distinct demographic with long-term treatment potential.
Milestone Reinforces the Potential for Cytisinicline as a First-in-Class Treatment for Vaping Cessation
SEATTLE and VANCOUVER, British Columbia, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company focused on the development and commercialization of cytisinicline for nicotine dependence, announced today the successful outcome of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). This meeting represents a key milestone in advancing cytisinicline’s development as a potential first-in-class treatment for nicotine e-cigarette or vaping cessation. Achieve obtained FDA agreement on the proposed single Phase 3 study design for cytisinicline treatment in vaping cessation and on the additional requirements for submitting a supplemental new drug application (sNDA) to expand cytisinicline for the treatment for vaping cessation.
The End-of-Phase 2 meeting resulted in alignment with the FDA on the proposed Phase 3 study design, including the inclusion/exclusion criteria, primary and secondary efficacy objectives, definition of vaping abstinence with biochemical verification, and other overall study assessments. The FDA agreed that one well-controlled Phase 3 trial (ORCA-V2), in addition to Achieve’s completed Phase 2 ORCA-V1 trial, would be acceptable for a vaping cessation indication as an sNDA. Additionally, the FDA agreed that the company’s safety exposure data from the ongoing ORCA-OL study would be adequate for the vaping cessation label expansion.
There are 11 million adults in the United States who use e-cigarettes, most of whom are 18 to 24 years old and have never smoked. Notably, about
“The success of our End-of-Phase 2 meeting reaffirms the clinical development strategy for cytisinicline and its potential as a groundbreaking therapy for nicotine dependence,” stated Cindy Jacobs, M.D., Ph.D., President and Chief Medical Officer of Achieve. “The FDA’s Breakthrough Therapy designation, granted earlier this year, has expedited and enhanced our interactions with the FDA thereby enabling us to receive timely feedback and accelerate the program’s timeline. We are steadfast on addressing the critical unmet need in vaping cessation and pioneering a path toward the first approved treatment for this growing public health challenge.”
The Phase 3 ORCA-V2 trial will assess the efficacy and safety of cytisinicline for nicotine e-cigarette cessation, building on the previous Phase 2 vaping cessation trial as well as the Phase 3 smoking cessation clinical trials with cytisinicline. The trial population and design are similarly aligned with Achieve’s successful Phase 2 ORCA-V1 trial. Achieve is currently targeting ORCA-V2 to initiate in the third quarter of 2025.
Key study design highlights include:
- Study Population: Adults 18 years of age or older who are dependent on nicotine e-cigarettes and who have failed at least one previous attempt to stop vaping nicotine.
- Study Design: ORCA-V2 will evaluate the efficacy and safety of 3 mg cytisinicline dosed three times daily (TID) for 12 weeks compared to placebo in approximately 800 adults who use e-cigarettes or nicotine vapes and do not currently smoke cigarettes. All participants will receive behavioral support for nicotine cessation and will be assessed throughout the 24-week trial duration.
- Study Objectives: The primary objective for ORCA-V2 mirrors the Phase 2 ORCA-V1 trial objective and will be weekly vaping abstinence with biochemical confirmation, measured during the last four weeks of treatment, weeks 9 to 12. The secondary objective will evaluate continuous vaping cessation from weeks 9 to 24. Safety, adherence to study treatment, and other patient-reported outcomes on vaping urges and craving symptoms will also be collected.
Rick Stewart, Chief Executive Officer of Achieve, commented, “Advancing our Phase 3 program for cytisinicline in vaping cessation marks a significant milestone. We remain confident in our ambition to revolutionize the category and provide a much-needed solution for quitting nicotine e-cigarettes and will continue to work closely with the FDA as the program advances.”
To date, Achieve has successfully completed two Phase 3 clinical trials of cytisinicline in more than 1,600 subjects who smoke combustible cigarettes and one Phase 2 clinical trial for adults who vape nicotine e-cigarettes and desire to quit. It completed enrollment of the ORCA-OL clinical trial, evaluating long-term safety exposure of the novel 3 mg cytisinicline TID dosing regimen in individuals who smoke cigarettes or vape nicotine, and expects to file its NDA submission for smoking cessation in the second quarter of 2025.
About ORCA-V1
The Phase 2 ORCA-V1 trial evaluated 160 adults who used e-cigarettes on a daily basis at five clinical trial locations in the United States. ORCA-V1 participants were randomized to receive 3 mg cytisinicline three times daily or placebo for 12 weeks in combination with standard cessation behavioral support. The dose and administration of cytisinicline in the ORCA-V1 study is identical to that used in the Phase 3 registrational trials for smoking cessation. ORCA-V1 was supported in part by the National Institute on Drug Abuse (NIDA) of the NIH through grant funding which was awarded in two phases totaling
About Achieve and Cytisinicline
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are approximately 29 million adults who smoke combustible cigarettes.1 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.2,3 More than
In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.4 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.5 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation to address this critical need.
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the 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 regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. 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 and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes 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 macroeconomic and geopolitical conditions, including inflation, volatile interest rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict 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.
Achieve Contact
Rich Cockrell
achv@cg.capital
(404) 736-3838
References
1VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.
2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
4Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.
5Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924
FAQ
What was the outcome of ACHV's End-of-Phase 2 FDA meeting for cytisinicline?
When will ACHV begin the Phase 3 ORCA-V2 trial for vaping cessation?
How many participants will be included in ACHV's ORCA-V2 Phase 3 trial?
What is the dosing regimen for cytisinicline in ACHV's ORCA-V2 trial?
