An estimated 22 million Americans suffer from sleep apnea, a condition which the National Heart, Lung and Blood Institute describes as repeated blockage of the upper airway during sleep, reducing or completely stopping airflow that goes undiagnosed, according to the American Sleep Apnea Association (ASAA).
Existing treatments for the illness range from avoiding sleeping on one’s back to various surgeries, or even a nighttime use of mandibular advancement devices that push the lower jaw or tongue forward, according to the ASAA’s site. But a new healthcare company aims to offer another solution.
Anapneo Therapeutics, a Chicago-based medical startup, recently secured a $250,000 investment from the George Shultz Innovation Fund of the University of Chicago. The company is currently in the advanced clinical development phase, but the funding will enable the company to begin clinical trials required by the FDA, said David McCormick, co-founder of Anapneo Therapeutics, professor of biology, and president and director of the IIT Research Institute.
The George Schultz Innovation Fund capital will be used to begin working on chemistry manufacturing and controls (CMC), an extensive part of the FDA's new drug approval application process, McCormick said.
“It’s a very highly regimented process,” McCormick said. “There are a lot of boxes that you have to check and a lot of milestones you have to achieve.”
There are three kinds of sleep apnea, according to ASAA. Obstructive sleep apnea is caused by an airway blockage, central sleep apnea is when the brain doesn’t tell the body to breathe, and mixed sleep apnea is a combination of both, per the ASAA.
With the drug that Anapneo Therapeutics is developing, patients can take the pill about 15 minutes or so before bed in order to get good quality sleep, McCormick said, noting that the drug will reach “pharmacologically active levels” within five or 10 minutes while the patient is in bed.
“Its pharmacokinetics are such that over an 8-hour period, the levels in the blood decrease to the point where they are no longer therapeutic and it dips below the threshold of activity,” McCormick said. “The person gets up in the morning and there’s no more biological activity, but they’ve had a good night’s sleep. And they get up and go to work.”
The company will likely conduct its clinical trials at a company that conducts phase 1 clinical trials, McCormick said. Nanduri Prabhakar, an Anapneo Therapeutics co-founder and professor of medicine and director of the Center for Systems Biology & Oxygen Sensing Section of Emergency Medicine at the University of Chicago, said several facilities have already expressed interest in conducting trials.
If all goes well, the company aims to get the product into the clinic within two to three years, said McCormick said, noting that it’s an optimistic goal that rests upon multiple factors. For one thing, the startup is seeking at least $25 million in investment capital, but that figure could change, he added.
“Nanduri and I are both scientists, and the goal here was to tackle a challenging scientific problem. It’s one that, quite frankly, no one has succeeded in challenging yet,” McCormick said. “The ultimate goal is to get this into the clinic and, hopefully, positively impact people’s lives.”
