Drug makers are making more bets on the nascent field of digital medicine. The latest example: Click Therapeutics announced Monday that it grabbed a $17 million investment led by Sanofi Ventures, the Cambridge, MA-based venture capital arm of the French pharmaceutical giant.
New York-based Click Therapeutics develops mobile apps intended to be prescribed by doctors to treat medical conditions, either on their own or in tandem with drugs or other standard treatments. The six-year-old company is working on software that delivers cognitive and “neurobehavioral” exercises, aimed at treating depression, insomnia, acute coronary syndrome, and chronic pain. Click said it plans to seek FDA clearance to sell those products as class 2 medical devices—a less rigorous regulatory process than drugs must undergo to win approval. The company said its lead experimental product, designed to treat major depressive disorder in adults, is entering a randomized, controlled, phase 3 trial.
It’s too early to tell whether any of Click’s products will pass muster with regulators, but it wouldn’t be the first company to receive FDA clearance for a “prescription digital therapeutic.” Pear Therapeutics, a five-year-old company located in Boston and San Francisco, broke through last September when it received clearance to sell its “reSET” software as a prescribed treatment for substance use disorder. Pharma giant Novartis has invested in Pear and is helping the startup launch its products commercially.
More prescription software products could hit the market in the coming months. Akili Interactive Labs, a Boston-based developer of mobile video games designed to assess and treat various cognitive disorders, has submitted its flagship experimental product to the FDA for review after it hit its main goal in a pivotal trial. If cleared by regulators, Akili says, it would be the first video game approved to treat a disease and the first “prescription digital medicine” for children with attention deficit hyperactivity disorder (ADHD). Four pharma companies—Merck, Shire, Amgen, and Pfizer—have each aligned with Akili either via investments or partnerships.
Meanwhile, Click Therapeutics already has a product on the market. “Clickotine” is an app designed to help people quit smoking, although the product doesn’t make any treatment claims and didn’t require FDA clearance to be marketed to the public, according to a statement e-mailed by a company spokesperson. The app digitally deploys smoking cessation tactics, such as teaching controlled breathing exercises; enabling users to log cigarettes smoked, cravings, and how they’re feeling; and sending encouraging messages. The app is being deployed by 30 clients, including insurance companies and employers, the company said in the e-mail.
Last year, Click published results of an initial single-arm clinical trial of Clickotine in the JMIR mHealth and uHealth journal. During the eight-week study, the 416 participants opened the app an average of 100 times and continued using it for an average of 5.3 weeks. At the end of the study, 45.2 percent of the participants reported they hadn’t smoked for at least seven days, and 26.2 percent of them said they hadn’t smoked for at least 30 days. The most common side effects were fatigue and mood changes, according to the study.
Click has raised about $20 million from investors to date, according to the e-mailed statement.
The startup is led by co-founder David Benshoof Klein, a former consultant to Pfizer and managing director of biotech investment firm Opus Point Partners, according to his LinkedIn profile. Klein’s co-founders include Bruce Leuchter, a medical doctor and psychiatrist who has also worked as a biotech analyst and healthcare investment banker in New York; Joshua Steinerman, a neuroscientist who previously worked at Teva Pharmaceuticals; Wei Zhou, a former user experience designer at Microsoft and Mozilla; and Victor Gao, who previously worked as a financial trader and studied biochemistry and computational neuroscience at Harvard, according to LinkedIn.
