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Achieve Life Sciences Is All Fired Up - Stock Soars Over 70%

pharma 051517 14mar19 lt

Shares of Achieve Life Sciences Inc. (ACHV) jumped over 70% in extended trading on Thursday as investors bet on the Company's Cytisinicline program, which is under development for smoking cessation.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

Last month, the Company reported encouraging final data from its phase I/II multi-dose, pharmacokinetic and pharmacodynamics clinical study of Cytisinicline in smokers. In the study, the effects of Cytisinicline at 1.5 mg and 3.0 mg dosage in 26 healthy volunteer smokers when administered over the standard 25-day course of treatment were evaluated.

All subjects had a significant and immediate reduction in cigarettes smoked within 2 days of initiating Cytisinicline treatment. By Day 26, subjects had an average 80% reduction in cigarettes smoked, 82% reduction in expired carbon monoxide, and 46% had stopped smoking.

A phase IIb trial evaluating Cytisinicline in both the 1.5 mg and 3.0 mg doses as well as three times daily dosing, both over 25 days, dubbed ORCA-1, is underway.
Today, the Company affirmed that the results of this trial are expected in mid-2019.

The Company has also initiated a trial meant to assess the maximum tolerated dose, or MTD, for a single administered oral dose of Cytisinicline. This study will be performed in smokers who will receive one single dose of Cytisinicline. The dosage of Cytisinicline will be increased in separate groups of subjects per dose level until stopping criteria are reached, based on the occurrence of dose-limiting adverse events.

Achieve Life revealed that the FDA has provided a full waiver for evaluating Cytisinicline in a pediatric population. The reasons for the full waiver were based on the low numbers of children smoking under the age of 12 and the logistical difficulties of recruiting treatment-seeking smokers in the adolescent age group, the Company noted.

The Company ended December 31, 2018, with cash of $14.7 million. As of March 14, 2019, the shares outstanding totaled 6.72 million.

ACHV closed Thursday's trading at $2.45, unchanged from the previous day's close. In after-hours, the stock jumped 72.65% to $4.23.

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