In this ongoing series, Velocity puts the spotlight on innovative Principal Investigators (PIs) whose work is changing the medical landscape at the intersection of research and patient care.
Velocity Team Contributes to Potential Breakthrough Sleep Apnea Treatment
Enjoying a good night’s sleep is vitally important both mentally and physically. Unfortunately, for many it’s a struggle to achieve each evening. In many cases, the person is suffering from one or more forms of sleep apnea, a potentially serious sleep disorder in which breathing repeatedly stops and starts, affecting sleep quality. If you snore loudly and feel tired, even after a full night’s sleep, you might have sleep apnea, according to The Mayo Clinic and other healthcare experts.
The main types of sleep apnea are:
- Obstructive sleep apnea (OSA), which is the more common form that occurs when throat muscles relax and block the flow of air into the lungs
- Central sleep apnea (CSA), which occurs when the brain doesn’t send proper signals to the muscles that control breathing
- Treatment-emergent central sleep apnea, also known as complex sleep apnea, which happens when someone has OSA – diagnosed with a sleep study – that converts to CSA when receiving therapy for OSA
Effective long-term management of sleep apnea has been both difficult and limited for patients and caregivers, says Luis De La Cruz, MD, a successful clinical trial Principal Investigator (PI) for more than 10 years, who has been part of the Velocity Clinical Research team since 2022. “I treat a lot of people for sleep apnea, and I can see their difficulties in using continuous positive airway pressure (CPAP) therapy as a permanent solution,” he explains. “As a healthcare professional, I share their frustration, and the need to have an alternative treatment to offer them beyond cumbersome masks and a few other more invasive treatments.”
Alongside his role as a PI at Velocity, Dr. De La Cruz is Medical Director of Sleep Services at Cherokee Medical Center in Gaffney, SC, associated with Spartanburg Regional Health System. He is also the Director of the Sleep Division at Upstate Lung and Critical Care. His specialized skills are used in Pulmonary and Internal Medicine studies at Velocity Greenville.
“There’s a desperate need for new solutions” to combat sleep apnea, says Dr. De La Cruz. Fortunately, there could be some good news on the horizon. Thanks in part to the work Dr. De La Cruz and others at Velocity have contributed to on the clinical research side, we may be on the cusp of game-changing treatments for sleep apnea. “We’re very excited about the results of a new trial that could give sleep apnea sufferers a whole new way to treat the problem,” Dr. De La Cruz adds.
A Velocity clinical trial site in Greenville, SC was selected to participate in a potentially breakthrough sleep apnea study for a sponsor focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders. “We are very excited about this opportunity,” says Dr. De La Cruz, noting the Phase 2 results and that Velocity is set to contribute to the Phase 3 study.
On May 21, Apnimed announced encouraging data from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study of one-month duration to treat sleep apnea without a mask, was featured in both an oral presentation and a poster presentation at The American Thoracic Society’s ATS 2023 International Conference in Washington, DC.
“[The MARIPOSA study] that found patients treated with the company’s lead candidate for OSA, AD109 (aroxybutynin + atomoxetine), had a statistically significant reduction in Apnea-Hypopnea Index (AHI) scores, improved daytime symptoms caused by OSA and was well-tolerated,” Larry Miller, MD, Chief Executive Officer of Apnimed said in a press release announcing the results. “These data support the dose and endpoint selection we have discussed with the U.S. Food and Drug Administration (FDA) for our Phase 3 studies scheduled to start in the second half of 2023.”
Dr. De La Cruz appreciates the opportunity to be part of the development team searching for a new way to treat sleep apnea. “Most treatments today are not successful, with a less than 50% compliance rate in part because the masks are so cumbersome,” he notes.
For the first time in years, Dr. De La Cruz is optimistic he’ll soon have something new and effective to offer his patients. “I’m ready to help my patients,” he says.
If you or someone you know is having trouble sleeping, healthcare professionals urge you to talk to your physician. You could also explore getting involved in a clinical trial that could help you and others, notes Dr. De La Cruz.
To join a clinical trial with Velocity, please visit our dedicated website for volunteers.
Follow this link to learn more about sleep studies at Dr. De La Cruz’s site in Greenville, SC.