Achieve Life Sciences to Present ORCA-V1 Data at SGIM Annual Meeting

May 17, 2024 – Achieve Life Sciences, Inc. (Nasdaq: ACHV), a leading pharmaceutical company focused on the development and commercialization of cytisinicline for smoking cessation and nicotine dependence, released data from the Phase 2 ORCA-V1 vaping cessation trial. These results will be showcased at the Society of General Internal Medicine (SGIM) Annual Meeting in Boston, MA.

Dr. Nancy Rigotti, the Principal Investigator of ORCA-V1, Professor of Medicine at Harvard Medical School, and Director of the Tobacco Research and Treatment Center at Massachusetts General Hospital, will present the trial's data. This Phase 2 study assessed the efficacy and safety of cytisinicline in adults aiming to quit nicotine e-cigarettes. The findings indicated that cytisinicline treatment more than doubled the chances of quitting compared to a placebo.

"We are privileged to present the ORCA-V1 findings at the SGIM Annual Meeting. This audience of healthcare providers is crucial in aiding individuals battling nicotine dependence in various forms," said Cindy Jacobs, MD, PhD, President and Chief Medical Officer at Achieve Life Sciences. "Cytisinicline has demonstrated promising results in smoking cessation, has been well tolerated, and we believe it will be essential in helping people quit vaping."

Dr. Rigotti will present during the “SAN2: Scientific Abstract Oral Presentations in Mental/Behavioral Health and Substance Use” session today at 2:45 PM EDT. The research was funded by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) under Award Number 4R44DA054784-02. The content remains the sole responsibility of the authors and does not reflect the official views of the NIH.

The Phase 2 ORCA-V1 trial involved 160 adults who regularly used e-cigarettes. Conducted at five clinical trial sites in the United States, participants were randomized to receive 3 mg cytisinicline three times daily or a placebo for 12 weeks, combined with standard cessation behavioral support. The dosage and administration in ORCA-V1 are identical to those used in Phase 3 trials for smoking cessation. ORCA-V1 was supported by NIH funding totaling $2.8 million.

Achieve Life Sciences focuses on addressing the global smoking health and nicotine addiction epidemic through developing and commercializing cytisinicline. In the United States alone, an estimated 28 million adults smoke combustible cigarettes. Tobacco use is the leading cause of preventable death globally, responsible for over eight million deaths worldwide and nearly half a million deaths annually in the U.S. Smoking contributes to 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of coronary heart disease deaths.

Furthermore, over 11 million adults in the United States use e-cigarettes, and in 2023, approximately 2.1 million middle and high school students reported using e-cigarettes. Currently, there are no FDA-approved treatments specifically for nicotine e-cigarette cessation.

Cytisinicline is a plant-based alkaloid with a strong affinity for nicotinic acetylcholine receptors. It is believed to aid in nicotine addiction treatment for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing withdrawal symptoms, and diminishing the reward and satisfaction from nicotine products. Cytisinicline is an investigational candidate not yet approved by the FDA for any indication in the United States.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!