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Achieve Life Sciences, Inc.

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ACHV - DAILY CHARTHi, today we are going to talk about Achieve Life Sciences and its current landscape. Achieve Life Sciences has been surrounded by increasing speculation over its shares after a couple of days ago had unveiled an update on the cytisinicline (a drug to aid smoking cessation ) clinical development program, as the FDA had agreed with the overall Phase 3 study designed by the company, that now can start this phase program on the first half of 2020. Despite the recent decline in the number of adults that currently smoke cigarettes in the United States, the company product has room to thrive as 34 million* American adults still smokes, and the public health effort works in favor to reduce this number and incentivize the smokers to look into methods to drop this addiction. Thank you for reading and leave your comments if you like. To have access to our exclusive contents, join the Traders Heaven today! Link Below. *CDC data - 2018 Disclaimer: All content of Golden Dragon has only educational and informational purposes, and never should be used or take it as financial advice.
NASDAQ:ACHV
by Igor-Silva
$ACHV BREAKOUT ON IMPROVED NICOTINE ADDICTION TRAIL********KEEP ON THE WATCHLIST FOR BREAKOUT, IMPROVED TRIAL RESULTS RELEASED, WITH CONFERENCE CALL TO FOLLOW LATER IN THE DAY******* Achieve Life Sciences, Inc. ACHV, clinical-stage pharmaceutical company focused on nicotine addiction, today announced positive results from the ORCA-1 dose-selection trial of cytisinicline for smoking cessation. The outcome of the 254-subject, ORCA-1 trial is the selection of 3.0 mg, three times daily (TID) for Phase 3 development. The primary endpoint was the reduction in daily smoking, a self-reported measure. Three of the four cytisinicline treatment arms demonstrated a statistically significant improvement, as defined in the protocol as p < 0.05, compared to placebo. The fourth arm trended to significance (p= 0.052). Across all treatment arms, over the 25-day treatment period, subjects on cytisinicline experienced a 74-80% median reduction in the number of cigarettes smoked, compared to a 62% reduction in the placebo arms. The secondary endpoint of the trial was a 4-week continuous abstinence rate, which is the relevant endpoint for regulatory approval. Cytisinicline treatment showed significant improvements in abstinence rates compared to placebo. The most impressive results were observed in the 3 mg TID treatment arm which demonstrated a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) and a continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline compared to 8% for placebo (p= 0.005). All four cytisinicline arms demonstrated statistically significant (p < 0.05) reductions in expired carbon monoxide (CO), a biochemical measure of smoking activity. Expired CO levels declined by a median of 71-80% in the cytisinicline treatment arms, compared to only 38% in the placebo arms. The lack of consistency in the reduction of expired CO levels compared to the self-reported data suggest potential under-reporting of cigarettes smoked by subjects on placebo. "The robust efficacy results in the simplified, three times daily dosing arms exceeded our expectations, particularly, the statistically significant abstinence rates. This is of importance given that a continuous abstinence rate is the endpoint for regulatory approval in smoking cessation trials," said Rick Stewart, Chairman and CEO of Achieve. "In addition to efficacy, the cytisinicline safety data observed in ORCA-1 reflects the historically strong safety profile already experienced in Central and Eastern Europe." Adherence to study treatment was greater than 98.5% across all arms and cytisinicline was well-tolerated with no serious adverse events reported. The most commonly reported (>5%) adverse events (AEs) across all cytisinicline treatment arms versus placebo were abnormal dreams, insomnia, upper respiratory tract infections, and nausea. In the 3 mg TID treatment arm versus placebo, the most common AEs were abnormal dreams, insomnia, and constipation (each 6% vs 2%), upper respiratory tract infections (6% vs 14%), and nausea (6% vs 10%). The Company expects to conduct further analyses of the ORCA-1 trial and submit data for presentation at a future medical meeting. Additionally, Achieve plans to discuss the trial's outcome with the FDA and finalize Phase 3 protocol details in the second-half of 2019. Achieve would like to thank the investigators, healthcare providers, and subjects whose commitment and efforts to ORCA-1 made this trial a success. Additional information on cytisinicline and the ORCA program can be found at www.achievelifesciences.com and www.orcaprogram.com. Conference Call DetailsAchieve will host a conference call at 8:30 a.m. Eastern time today, Tuesday, June 11, 2019. To access the webcast, log on to the investor relations page of the Achieve website at
NASDAQ:ACHV
by DEXWireNews