Will The New Smoking Cessation Product Achieve ORCA Trial Goals?

In the United States, cigarette smoking continues to be the primary source of preventable disease, disability, and death, according to the CDC. It is estimated that nearly 31 million adults in the United States currently smoke cigarettes, and over 16 million Americans live with a smoking-related disease.

Nicotine replacement therapies like skin patches, chewing gum, and lozenges, which are sold over the counter; prescription smoking cessation products that contain nicotine like nicotine spray and nicotine inhaler; and two prescription smoking cessation products that do not contain nicotine like Chantix and Zyban are the smoking cessation products approved or cleared by the FDA.

The company we are profiling today is Achieve Life Sciences Inc. (ACHV), which is developing a new solution to quit smoking.

The investigational product in focus is Cytisinicline, a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor, a receptor considered to play a crucial role in sustaining smoking behaviors.

A phase III trial evaluating the smoking cessation efficacy, safety, and tolerability of 3 mg Cytisinicline dosed three times daily for either 6 or 12 weeks compared with placebo is underway.

This trial, dubbed ORCA-3, completed enrollment of 792 adults who currently smoke cigarettes daily and intend to quit smoking, across 20 sites, in the U.S., last September. Topline data from this study is expected next quarter.

The company is also exploring Cytisinicline as an aid in e-cigarette cessation.

Although e-cigarettes that contain nicotine are considered to be less harmful than traditional cigarettes, they are still addictive and can deliver harmful chemicals that can harm the lung or heart. It is estimated that there are nearly 11 million adults in the United States who use electronic cigarettes, commonly referred to as vaping.

A phase II trial evaluating the efficacy and safety of Cytisinicline in adult users of nicotine e-cigarettes or vapes, dubbed ORCA-V1, is ongoing.

This study completed enrolment of 160 subjects across 5 clinical trial locations in the United States, early this month. Topline data from this study is also anticipated in the second quarter of this year.

Market opportunity for Smoking Cessation product

Pfizer’s Chantix has been one of the most successful smoking cessation products in the market. It generated global sales of $1.1 billion at its peak before it was withdrawn from the market in June 2021 due to high levels of nitrosamines, which were deemed unacceptable.

The first and only generic version of Pfizer’s Chantix was launched by Endo International plc (ENDP) in September 2021.

Achieve Life Sciences sees a substantial opportunity in the smoking cessation market due to the lack of novel treatments for nicotine addiction and the advantage of Cytisinicline over Chantix, which has significantly fewer adverse events.

Cash position

The company, which had cash of $18.2 million as of September 30, 2022, raised additional cash of $18.9 million through a private placement last November.

ACHV has traded in a range of $2.00 to $8.13 in the last 1 year. The stock closed Friday’s trading at $5.36, up 1.90%.

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