Chrono Therapeutics announced that clinical data of its smoking cessation technology showed a statistically significant reduction in nicotine cravings in a small trial of adult male smokers.
The company has developed a wearable transdermal drug delivery device which times nicotine delivery to when smokers have their strongest cravings. For example, 75% of all smokers reach for their first cigarette within 30 minutes of waking up. The Chrono Solution is designed to deliver the first dose of nicotine replacement therapy (NRT) shortly before a smoker wakes up and then creates a pattern of “peaks and troughs” of nicotine delivery throughout the rest of the day to assure the smoker has more nicotine support when cravings are predicted to be strongest.
The randomized, double blinded study involved 24 adult males who smoked 11 or more cigarettes per day, and were divided into two groups.“Gums and patches are designed to help manage cravings, but they are only 5 to 9 percent effective,” Alan Levy, Ph.D., chairman and CEO of Chrono Therapeutics, said in a statement. “Our goal is to solve this crisis of public health with an innovative, integrated smoking cessation solution, and the data we presented demonstrates that we are on the right path.”
The clinical trial was a randomized, double blinded study of 24 adult males who smoked 11 or more cigarettes per day, who were divided into two groups. Test group subjects had nicotine administered over a 30-hour time period via Chrono’s prototype device while that delivered nicotine according to Chrono’s “peaks and troughs” profile. On the other hand, the control group had a placebo solution, with no nicotine, administered at the same intervals via the same prototype device. Across both groups, subjects showed no serious adverse events or study withdrawals due to an adverse event. Also, skin irritation assessment showed no signs of irritation or erythema.
The trial used three different methods to assess cravings: the Questionnaire for Smoking Urges (QSU), the Mood and Physical Symptoms Scale (MPSS) and a single craving question, each of which is a validated tool to assess cravings. When compared to subjects treated with placebo, test subjects had a statistically significant and clinically meaningful reduction in cravings for all assessment methods (p=0.035; p=0.034 and p=0.016, respectively).
“Achieving statistical significance in a 24-subject trial is very striking and happens infrequently in biopharma; so these results are very encouraging,” noted Wende Hutton, general partner at Canaan Partners and a member of Chrono’s board of directors.
According to CrunchBase, Chrono Therapeutics has raised $34.9 million to date, including a massive Series A round of $32 million in June 2014.