Crown Point company’s medicine helps patients emerge faster from anesthesia
When Brett Dines came out of retirement to start a pharmaceutical company, he knew what to name it. OYE Therapeutics in Crown Point is an acronym for the first thing hospital staffers say to patients when they’re waking up from anesthesia: “Open your eyes.”
His company focuses on this critical moment when patients begin to regain consciousness and breathe on their own after the effects of anesthesia, said Dines, who is OYE’s president and CEO.
As a pharmacist who also has a background as an award-winning salesman with Cardinal Health and a division leader for Walgreens corporation, Dines retired at age 50. He was enjoying his time on the golf course, but then, he said, he “ended up at a meeting at the FDA and was reminded of research going on in the country about the reversal of general anesthesia.”
Medication isn’t available to speed the process of “emergence,” or waking up, from anesthesia. So, helping patients breathe throughout this critical phase becomes a “judgment call fraught with time-uncertainty” for anesthesiologists, said Dr. Jose Melendez, retired vice chairman of clinical affairs for the Department of Anesthesiology at the University of Colorado. He now is a board member and investor in OYE Therapeutics.
The waking process could take two minutes for one person or 20 minutes to an hour for another, Dines said. Plenty of common medical conditions — such as asthma, obesity, sleep apnea and diabetes — can complicate the process, increasing the risk that patients could struggle to resume breathing or end up with fluid in their lungs.
Melendez said it falls on the anesthesia team to protect patients with intubation when necessary during surgery and by “only removing the breathing tube when they believe the patient is able to protect their airway.” When emergence takes longer, he said, this can lead to undesirable outcomes.
“If we could reduce the time by a few minutes,” Melendez said, “we might be able to save lives.”
Dines learned during the FDA meeting about a medication under development since 2008 by the University of Chicago. It shows potential to improve the emergence process. The idea was an intravenous formulation of caffeine, which could help reverse the effects of anesthetics, so patients could wake up and begin breathing on their own — faster.
Dines knew from his training as a pharmacist that caffeine naturally stimulates breathing and naturally reverses the effects of many drugs on the central nervous system. He was immediately interested.
“There’s a real gap in care, here, that this product could potentially solve,” he said.
Dines paused his retirement and began setting up the company that became OYE. Once the business was established in 2019, Dines, now 56, was granted rights to the IV caffeine product from the University of Chicago. He started working with his alma mater, Purdue University, to obtain market exclusivity and intellectual property rights to the formulation.
Dines and his OYE team of about 10 experts in medicine, hospitals and related fields planned to start clinical trials on their new medication in January. The process is expected to be completed in June. Then, OYE hopes to initiate a new drug application with the FDA.
Melendez said he anticipates positive results from the clinical trial to “clearly document how quickly this medication works, how safe it is and how efficient it is.”
OYE’s formulation of intravenous caffeine also has another major upside, Dines said. It allows the pain-controlling effects of opioids to continue working, so patients can still feel relief, even while waking up quicker and safer after surgery.
“The novelty is it doesn’t reverse pain control in a number of settings where pain control is absolutely imperative to maintain,” Dines said.
This means the new product potentially could be used as a complement to the opioid overdose reversal drug, naloxone, extending its duration and offering a different way of working in the body.
Dines said OYE’s caffeine formulation would stimulate the breathing process without triggering opioid withdrawal, which can cause those dealing with addiction to seek another hit after being revived — and risk overdosing again. He said a couple of OYE’s investors are ambulance company owners who see the new drug’s potential to work alongside naloxone against the opioid epidemic.
“They thought for certain this product would be approved by the chief medical officers in some very large cities for that purpose,” Dines said.
OYE Therapeutics has raised about $25 million for the development of its intravenous caffeine product, with $20 million coming from the Department of War in a research partnership with the Uniformed Services University of the Health Sciences.
Battlefield medicine is one instance where pain control remains critical after surgery, so Dines said the military is excited to see proof that the new medicine assists with anesthesia emergence.
“You’re not reliant on the opioid receptor site and reversing that. The opioid can still be on board in the patient, offering pain control without causing respiratory depression,” Dines said. “We’re stimulating the body to respond to the amount of carbon dioxide in the blood, and in doing so, the patient starts breathing.” •
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