Achieve Life Sciences Inc (NASDAQ:ACHV), a clinical-stage pharmaceutical firm committed to the international commercialization and development of cytisine for smoking cessation, posted preliminary report from their Phase 1/2 multi-dose, PK/PD clinical trial of cytisine.
The trial, commenced in October 2017, assessed the repeat-dose PD and PK effects of 3mg and 1.5mg cytisine in 24 healthy subject smokers aged 18-65 years when given over the typical 25-day course of treatment. As per the update, the PK data indicated anticipated increases in plasma concentration between the higher and standard doses of cytisine with no proof of drug accumulation.
Smokers in the trial were not needed to have a predetermined or designated quit date, however, 58% of the people enrolled in the trial recorded biochemically confirmed smoking abstinence at day twenty-six. Half of the subjects in the trial that were on the 1.5mg arm and 67% of the subjects in the trial that were on the 3mg arm recorded abstinence on day 26. Enrollments who did not record abstinence had a considerable decline in count of daily cigarettes smoked by the close of treatment.
Achieve Life Sciences reported that Cytisine was well-tolerated. Reported adverse events were mainly mild and short-lived. Moreover, transient headache was the prevalent reported event, however was not treatment-limiting. As per the report, no adverse events were serious, severe or led to drawing from the trial. Study data will be comprised in a clinical symposium on cytisine at the SRNT Annual Meeting on February 23 in Baltimore.
Dr. Cindy Jacobs, the Chief Medical Officer and Executive Vice President at Achieve, expressed that the abstinence rates noted with cytisine are mainly impressive provided the 25-day treatment period. Additionally, subjects didn’t commit to quitting and obtained merely minimal behavioral support. Establishing an actual quit date and obtaining improved behavioral support are major factors to enhance smoking cessation outcomes.