▎ WuXi AppTec content team editor
Achieve Life Sciences today announced that its research therapy, cytisinicline, has yielded positive top-line results in a Phase 3 clinical trial orCA-2 to help adult smokers quit. Compared with placebo, patients treated with plantagenet at 6 or 12 weeks were 8.0-fold and 6.3-fold more likely to quit smoking, respectively.
Tobacco use is the leading cause of preventable death, causing more than 8 million deaths globally each year. More than 87% of lung cancer deaths, 61% of lung disease deaths and 32% of coronary heart disease deaths are related to smoking and secondhand smoke exposure.
Achieve Life Sciences focuses on developing plantagenet to address smoking and nicotine addiction worldwide. Plantellin is a plant base with a high binding affinity with nicotinic acetylcholine receptors. It is thought to reduce the severity of nicotine withdrawal symptoms by interacting with nicotine receptors in the brain and to help quit smoking by lowering the rewards and euphoria associated with smoking.
In this Phase 3 clinical trial, 810 adult smokers were randomized with a placebo, 3 mg of plantagenet (three times daily) for 6 or 12 weeks. The average age of the subjects was 54 years, with an average of 20 cigarettes per day at baseline, and the median smoking history was 38 years, after having previously tried to quit smoking an average of 4 times.
The trial results showed that subjects treated with plantagenet at 12 weeks had a 32.6% chance of quitting smoking within the last 4 weeks of treatment compared with the placebo group, which was 6.3 times higher than that in the placebo group (7.0%)(p
In addition, secondary endpoints measured a patient's chance of quitting smoking after stopping treatment. In the patient group who received 12 weeks of treatment, the sustained smoking cessation rate from the 9th week to the 24th week of treatment was 21.1%, which was 5.3 times that of the placebo group (4.8%)(p
▲ Subjects who received 12 weeks of plantagenet treatment had a significantly higher chance of quitting smoking than the control group (Source: Achieve Life Sciences official website)
Subjects treated with plantagenet at 6 weeks had a 25.3% chance of quitting smoking in the last 4 weeks of treatment, 8 times higher than in the placebo group (4.4%). The sustained smoking cessation rate in this group of subjects from week 3 to week 24 after the start of treatment was 8.9%, which was 3.7 times higher than that of the placebo group (2.6%).
Plantagenet was well tolerated and no treatment-related serious adverse events were identified.
"These positive results are encouraging. We are happy for those who have successfully quit smoking. John Bencich, CEO of Achieve Life Sciences, commented, "If approved by the US FDA, plantagenet could become the first new drug approved to aid smoking cessation in nearly two decades and an important treatment option for smoking cessation." ”
Resources:
[1] Achieve Life Sciences Announces Successful, Statistically Significant Smoking Cessation Results in Phase 3 ORCA-2 Clinical Trial of Cytisinicline in Adult Smokers. Retrieved April 27, 2022, from https://www.globenewswire.com/news-release/2022/04/27/2430191/0/en/Achieve-Life-Sciences-Announces-Successful-Statistically-Significant-Smoking-Cessation-Results-in-Phase-3-ORCA-2-Clinical-Trial-of-Cytisinicline-in-Adult-Smokers.html
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