Achieve Life Sciences Announces Positive Outcome of Second Data Safety Monitoring Committee Review for the ORCA-OL Clinical Trial
Achieve Life Sciences (NASDAQ: ACHV) announced positive results from the second Data Safety Monitoring Committee (DSMC) review of its ORCA-OL trial, evaluating long-term exposure of 3 mg cytisinicline for smoking and nicotine vaping cessation. The DSMC found no unexpected treatment-related adverse events and noted excellent medication adherence, allowing the study to continue without modifications.
The trial has reached significant milestones, including the enrollment of 479 participants across 29 U.S. clinical sites and achieving the goal of over 300 participants completing six months of cytisinicline treatment. This milestone is important for the company's planned New Drug Application (NDA) submission in Q2 2025.
The ORCA-OL trial aims to meet FDA safety data requirements, which include six-month safety data from at least 300 participants and one-year cumulative exposure data from minimum 100 participants prior to potential NDA approval. Achieve has already completed two Phase 3 trials involving over 1,600 subjects.
Achieve Life Sciences (NASDAQ: ACHV) ha annunciato risultati positivi dalla seconda revisione del Data Safety Monitoring Committee (DSMC) del suo trial ORCA-OL, che valuta l'esposizione a lungo termine di 3 mg di citisinicline per la cessazione del fumo e dell'uso di sigarette elettroniche. Il DSMC non ha riscontrato eventi avversi imprevisti legati al trattamento e ha notato un'ottima aderenza al farmaco, permettendo allo studio di continuare senza modifiche.
Il trial ha raggiunto traguardi significativi, inclusa l'arruolamento di 479 partecipanti in 29 siti clinici negli Stati Uniti e il raggiungimento dell'obiettivo di oltre 300 partecipanti che completano sei mesi di trattamento con citisinicline. Questo traguardo è importante per la prevista presentazione della Nuova Domanda di Farmaco (NDA) dell'azienda nel secondo trimestre del 2025.
Il trial ORCA-OL mira a soddisfare i requisiti di sicurezza dei dati richiesti dalla FDA, che includono dati di sicurezza sei mesi da almeno 300 partecipanti e dati di esposizione cumulativa di un anno da un minimo di 100 partecipanti prima di una potenziale approvazione dell'NDA. Achieve ha già completato due studi di Fase 3 coinvolgendo oltre 1.600 soggetti.
Achieve Life Sciences (NASDAQ: ACHV) anunció resultados positivos de la segunda revisión del Comité de Monitoreo de Seguridad de Datos (DSMC) de su ensayo ORCA-OL, que evalúa la exposición a largo plazo de 3 mg de citisiniclina para la cesación del humo y el vapeo de nicotina. El DSMC no encontró eventos adversos inesperados relacionados con el tratamiento y observó una excelente adherencia a la medicación, permitiendo que el estudio continúe sin modificaciones.
El ensayo ha alcanzado hitos significativos, incluida la inscripción de 479 participantes en 29 sitios clínicos de EE. UU. y el cumplimiento del objetivo de más de 300 participantes que completan seis meses de tratamiento con citisiniclina. Este hito es importante para la presentación planificada de la Nueva Solicitud de Medicamento (NDA) de la compañía en el segundo trimestre de 2025.
El ensayo ORCA-OL tiene como objetivo cumplir con los requisitos de datos de seguridad de la FDA, que incluyen datos de seguridad a seis meses de al menos 300 participantes y datos de exposición acumulativa de un año de un mínimo de 100 participantes antes de una posible aprobación de la NDA. Achieve ya ha completado dos ensayos de Fase 3 involucrando a más de 1,600 sujetos.
Achieve Life Sciences (NASDAQ: ACHV)는 금연 및 니코틴 흡연 중단을 위한 3mg 사이티신클라인의 장기 노출을 평가하는 ORCA-OL 시험의 두 번째 데이터 안전 모니터링 위원회(DSMC) 검토에서 긍정적인 결과를 발표했습니다. DSMC는 예상치 못한 치료 관련 부작용이 없음을 확인하였으며, 약물 복용이 우수하다고 언급하며 연구가 수정 없이 계속될 수 있도록 하였습니다.
이 시험은 미국 내 29개 임상 사이트에서 479명의 참가자를 모집하고, 300명 이상의 참가자가 6개월 동안 사이티신클라인 치료를 완료하는 목표를 달성하는 등 중요한 이정표를 도달하였습니다. 이 이정표는 2025년 2분기에 회사의 신약 신청(NDA) 제출 계획에 중요합니다.
ORCA-OL 시험은 FDA의 안전 데이터 요구 사항을 충족하는 것을 목표로 하며, 여기에는 최소 300명의 참가자에게서 6개월 안전 데이터와 최소 100명의 참가자에게서 1년 누적 노출 데이터가 포함됩니다. Achieve는 이미 1,600명 이상의 피험자를 포함한 두 가지 3상 시험을 완료했습니다.
Achieve Life Sciences (NASDAQ: ACHV) a annoncé des résultats positifs de la deuxième évaluation du Data Safety Monitoring Committee (DSMC) de son essai ORCA-OL, qui évalue l'exposition à long terme de 3 mg de cytisinicline pour l'arrêt du tabac et du vapotage de nicotine. Le DSMC n'a trouvé aucun événement indésirable lié au traitement et a noté une excellente adhérence au traitement, permettant à l'étude de se poursuivre sans modifications.
L'essai a atteint des jalons significatifs, y compris l'inscription de 479 participants dans 29 sites cliniques aux États-Unis et l'atteinte de l'objectif de plus de 300 participants ayant complété six mois de traitement par la cytisinicline. Ce jalon est important pour la soumission prévue de la demande de nouveau médicament (NDA) par l'entreprise au deuxième trimestre de 2025.
L'essai ORCA-OL vise à satisfaire aux exigences de données de sécurité de la FDA, qui comprennent des données de sécurité sur six mois d'au moins 300 participants et des données sur l'exposition cumulée sur un an d'au moins 100 participants avant une éventuelle approbation de la NDA. Achieve a déjà complété deux essais de Phase 3 impliquant plus de 1 600 sujets.
Achieve Life Sciences (NASDAQ: ACHV) hat positive Ergebnisse aus der zweiten Überprüfung durch das Data Safety Monitoring Committee (DSMC) seiner ORCA-OL Studie bekannt gegeben, die die langfristige Exposition von 3 mg Cytisinicline zur Raucherentwöhnung und zum Aufhören mit dem Dampfen von Nikotin untersucht. Das DSMC stellte fest, dass keine unerwarteten behandlungsbedingten Nebenwirkungen auftraten, und bemerkte eine ausgezeichnete Medikamentenadhärenz, wodurch die Studie ohne Modifikationen fortgesetzt werden konnte.
Die Studie hat bedeutende Meilensteine erreicht, darunter die Rekrutierung von 479 Teilnehmern an 29 klinischen Standorten in den USA und die Erreichung des Ziels von über 300 Teilnehmern, die sechs Monate Behandlung mit Cytisinicline abgeschlossen haben. Dieser Meilenstein ist wichtig für die geplante Einreichung des New Drug Application (NDA) im 2. Quartal 2025.
Die ORCA-OL Studie zielt darauf ab, die Sicherheitsdatenanforderungen der FDA zu erfüllen, zu denen sechs Monate Sicherheitsdaten von mindestens 300 Teilnehmern und einjähriger kumulativer Expositionsdaten von mindestens 100 Teilnehmern vor der möglichen NDA-Zulassung gehören. Achieve hat bereits zwei Phase-3-Studien mit über 1.600 Probanden abgeschlossen.
- DSMC review confirmed positive safety profile with no unexpected adverse events
- Achieved required milestone of 300+ participants completing 6-month treatment
- Successfully enrolled 479 participants across 29 U.S. clinical sites
- On track for NDA submission in Q2 2025
- None.
Insights
The second positive DSMC review of Achieve's ORCA-OL trial marks a critical regulatory milestone that substantially de-risks the company's path to NDA submission. The clean safety profile, characterized by no unexpected adverse events and excellent medication adherence, is particularly noteworthy given the historical challenges faced by smoking cessation treatments regarding side effects and compliance.
The trial has strategically satisfied two important FDA requirements: enrolling 479 participants and achieving 300+ participants completing six months of treatment. This positions Achieve to submit its NDA in Q2 2025 with a comprehensive safety database that exceeds typical Phase 3 requirements, potentially streamlining the review process.
The commercial implications are substantial. As the first potential new prescription treatment for smoking cessation in nearly two decades, cytisinicline could capture significant market share if approved. The strong safety profile, combined with previously demonstrated efficacy, could position it as a preferred option among healthcare providers who have been to existing treatments with known side effect profiles.
Looking ahead, the continued monitoring for one-year cumulative exposure data in 100+ participants during the NDA review period provides an additional layer of safety validation. This thorough approach to safety documentation aligns with heightened regulatory scrutiny in the smoking cessation space and could facilitate both approval and subsequent market adoption.
The positive DSMC review strengthens Achieve's position in the $7+ billion global smoking cessation market. The company's execution in meeting FDA requirements positions cytisinicline for potential commercialization in a market that has seen innovation, creating a significant opportunity for market penetration.
The robust safety profile and excellent adherence rates could translate into favorable pricing and reimbursement decisions. Healthcare payers typically value treatments that demonstrate both safety and compliance, as these factors contribute to better outcomes and potential cost savings in the healthcare system.
From a competitive standpoint, being the first new prescription treatment in nearly 20 years provides Achieve with a unique market position. The timing is particularly advantageous given increasing regulatory pressure on nicotine products and growing awareness of vaping-related health concerns. The dual application for both traditional smoking and vaping cessation expands the addressable market and positions cytisinicline as a versatile treatment option.
No Safety Concerns Identified by DSMC in the ORCA-OL Long-Term Exposure Trial
Achieve Reiterates Planned Cytisinicline NDA Submission in Q2 2025
SEATTLE and VANCOUVER, British Columbia, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that the Data Safety Monitoring Committee (DSMC) has recently completed its second independent review of the ongoing ORCA-OL trial, evaluating long-term exposure of the novel 3 mg cytisinicline treatment dosing regimen in individuals who smoke cigarettes or vape nicotine.
Following this second comprehensive review of available safety data, the DSMC stated that it did not identify any unexpected treatment-related adverse events and that the participants’ adherence to their cytisinicline medication was excellent. Overall safety data remains consistent with previous findings. The DSMC concluded the study may continue as planned without any modifications.
“The positive outcome of the DSMC’s second review continues to confirm the previous findings from our Phase 2 and Phase 3 trials regarding the overall safety of cytisinicline,” said Cindy Jacobs, PhD, MD, President and Chief Medical Officer of Achieve. “This reinforces our confidence in the cytisinicline safety profile from the ORCA-OL trial and the broader ORCA program, moving us closer to filing our cytisinicline New Drug Application or NDA.”
In October 2024, Achieve announced the completion of the ORCA-OL trial enrollment, with 479 participants enrolled across 29 clinical trial sites in the United States. All participating sites and individuals were previously involved in Achieve’s ORCA “Ongoing Research of Cytisinicline for Addiction” program, which focused on smoking and e-cigarette cessation. In January 2025, Achieve announced that the ongoing ORCA-OL clinical trial had reached its goal of at least 300 participants completing six months of cumulative cytisinicline treatment, which was an important milestone for proceeding with the company’s planned NDA filing.
Rick Stewart, Chief Executive Officer of Achieve, added, “Achieve remains on track with our expected NDA submission next quarter for cytisinicline as a treatment of nicotine dependence for smoking cessation. We believe it will be the first new prescription treatment in nearly 20 years to provide physicians and smokers with an important new tool to stop smoking. Achieve remains focused on and committed to addressing the public health crisis of nicotine dependence.”
The ORCA-OL clinical trial is designed to satisfy the U.S. Food and Drug Administration’s (FDA) long-term exposure safety data requirements for cytisinicline’s potential approval. The FDA requested six-month safety exposure data from at least 300 participants who have been treated with cytisinicline to be included in the company’s planned NDA, with one-year cumulative exposure safety data from a minimum of 100 participants treated with cytisinicline submitted during the NDA review period, prior to potential NDA approval.
To date, Achieve has successfully completed two Phase 3 clinical trials of cytisinicline in more than 1,600 subjects who smoke cigarettes and have the desire to quit. The ORCA-OL clinical trial continues to evaluate longer-term safety exposure of the novel 3 mg cytisinicline three times a day dosing regimen in individuals who want to end their nicotine dependence.
About ORCA-OL Trial
ORCA-OL is an open-label trial designed to evaluate the long-term exposure of 3 mg cytisinicline treatment dosed three times daily in adults 18 years of age or older who want to quit smoking or vaping and is being conducted at 29 clinical sites across the United States. The trial results are expected to meet the FDA's requirement for safety data from at least 300 participants treated with cytisinicline over a cumulative six-month period for the NDA submission. Additionally, data on at least 100 subjects treated for a cumulative one-year period will be provided prior to potential product approval.
About Achieve Life Sciences, Inc.
Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. The company has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and one Phase 2 study with cytisinicline in vaping cessation. The company has fully enrolled its ongoing open-label safety study with cytisinicline and plans to submit its new drug application for smoking cessation in Q2 2025. Achieve has also conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.
About 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 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
Nicole Jones
ir@achievelifesciences.com
425-686-1510
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
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