Digital health company Chrono Therapeutics has landed $47.6 million from investors to fund its drive toward FDA approval of a wearable quit-smoking system it hopes will rival products like Pfizer’s drug Chantix.
Chrono’s product combines a programmed patch delivering tailored doses of nicotine with a motivational app to deal with the psychological aspects of addiction to smoking. The company is betting that the paired approach will be more effective than either tactic by itself—whether a smoker uses available drug therapies, such as Chantix and nicotine patches, or anti-smoking behavioral coaching alone.
Because smoking takes a high toll on overall health, employers and insurance plans routinely cover the cost of treatments that help people quit. Revenue for well-established products can approach $1 billion a year, Chrono product and marketing vice president Jenny Hapgood says.
Hayward, CA-based Chrono has now raised a total of nearly $80 million from outside investors. Following a $32 million Series A financing round in mid-2014, the company attracted support and a $100,000 investment from San Francisco-based digital health fund Rock Health.
Chrono’s $47.6 million Series B funding round, announced this week, was led by Kaiser Permanente Ventures, joined by Endeavour Vision, Xeraya Capital Labuan Ltd, Asahi Kasei, Emergent Medical Partners, Hikma Ventures, Cota Capital, and Mission Bay Capital. Previous investors also participated, including Canaan Partners, 5AM Ventures, Fountain Healthcare Partners, GE Ventures, and Mayo Clinic.
Under guidance from the FDA, Hayward, CA-based Chrono is preparing to conduct a clinical trial in which 100 to 200 smokers will use the company’s wearable system for six weeks, with a six-month follow-up period, Hapgood says. Participants in a control arm of the trial will receive a placebo through the wearable patch rather than the nicotine doses meted out during the day to smokers in the experimental arm of the trial. All participants will have access to the behavioral therapy app through their smartphones.
Hapgood says the company has already conducted a one-day trial of the effect of the nicotine delivery system alone, which showed a statistically significant decline in the self-reported urge to light up among the 24 smokers participating.
Users have a limited ability to customize the system by entering the time of day when they’re likely to wake up. The Chrono patch then delivers the first nicotine dose before that wake-up time, to forestall the common craving to smoke soon after waking because the body’s nicotine levels have dropped during a night’s sleep. Users can change the wake-up time daily according to their schedules, Hapgood says.
Every night before going to bed, smokers attach a new nicotine cartridge to the patch so the next day’s doses will be ready to deliver. The dose level varies throughout the day to help users cope with typical peak periods in the desire to smoke, such as after meals. Under Chrono’s system, the amount of nicotine in the cartridges tapers off gradually over the weeks of treatment.
The FDA has informed the company that its quit-smoking system will be regulated as a drug rather than as a device, and if approved, could be sold as an over-the-counter product, Hapgood says. Chrono expects to price the product at about $500 for a ten-week course of treatment—-aiming at a level near the cost of nicotine gum for the same period, but lower than the $650 to $800 price of Chantix.
If all goes well, Chrono might submit its application for approval to the FDA in 2018, and the product could be on store shelves in 2018 or early 2019. The company is simultaneously pursuing approval from regulators for the European Union, Hapgood says. It’s also looking at other international markets.
Chrono is interested in teaming up with a larger partner with the resources to promote its anti-smoking system if and when it’s approved, Hapgood says. The alternative would be to raise more equity financing or go public, she says.
Another plan on the horizon is to adapt the Chrono system for other disorders where there would be an advantage in being able to precisely control a drug dosage over the course of a day or a long course of treatment, Hapgood says. Two possibilities are Parkinson’s Disease, where dose timing might help minimize the tremors that can be a side effect of a drug used for the illness, and addiction to prescription opioids, where metered drug delivery might be better than dispensing a full bottle of pills to patients and relying on their will-power to limit their daily intake and taper it off over time, Hapgood says.