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ACHV: Final Enrollee, Final Visit

By John Vandermosten, CFA

NASDAQ:ACHV

Achieve Life Sciences, Inc. (ACHV) announced that its final enrollee had completed their final visit in the Phase IIb ORCA-1 trial on Wednesday. We expect the company will lock the database and perform analysis over the next several weeks and then report topline data by mid-year.

As a reminder the ORCA-1 (Ongoing Research of Cytisinicline for Addiction) trial is evaluating the effectiveness of cytisinicline for smoking cessation. The 254 enrollee study began in October 2018 with eight US-based centers evaluating the 1.5 mg and 3.0 mg doses of cytisinicline over the 25 day administration period using either a declining titration schedule or three daily doses.

The trial was designed as a multicenter, double blind, placebo-controlled trial in adult smokers randomized in a 2:2:1 ratio at 1.5 mg, 3.0 mg and placebo. It included behavioral support in the three arms and also stratified subjects by weight class.

The primary endpoint is the percentage reduction in cigarettes smoked during treatment. Secondary analyses will examine smoking cessation rates, safety and compliance. The Data Safety Monitoring Committee conducted its final review shortly before the announcement and concluded that there were no safety concerns or study conduct issues and that the trial should proceed as planned.

In the previous Phase I/II PK/PD repeat dose trial, 50% of the subjects in the 1.5 mg cytisinicline arm and 67% of the 3.0 mg arm achieved abstinence on day 26. Overall, subjects experienced an 80% reduction in cigarettes smoked and an 82% reduction in expired carbon monoxide in this study.

Assuming that favorable data is presented from the ORCA-1 trial, we anticipate additional detail on timing and design of two Phase III trials, the first of which will launch prior to year-end 2019. We highlight to investors that there will be a capital raise prior to their start that will expand the opportunity for participation in this well-understood molecule that is anticipated to address the unmet need in nicotine addiction. See our initiation for additional detail.

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