Nyxoah SA’s DREAM US pivotal study, designed to support the marketing authorization of the Genio hypoglossal nerve stimulation system for obstructive sleep apnea in the United States, achieved a statistically significant reduction in the co-primary endpoints of 12-month apnea-hypopnea index (AHI) responder rate, the company announced. 

This multicenter, prospective, open-label, interventional study enrolled 115 patients and has co-primary efficacy endpoints of the AHI responder rate, per the Sher criteria, and the oxygen desaturation index responder rate, both measured at 12 months. 

Subjects also were required to sleep supine for at least 60 minutes at their 12-month polysomnography test. 

Study participants entered the DREAM study with a mean AHI of 28, mean oxygen desaturation index of 27, and mean body mass index of 28.5. At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria, resulting in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects were determined to be oxygen desaturation index responders, resulting in an oxygen desaturation index responder rate of 71.3% (p<0.001). 

Subjects demonstrated a median 12-month AHI reduction of 70.8%, with similar AHI improvements in supine and non-supine sleeping positions. The safety results for the investigational treatment were favorable, with 11 serious adverse events, or SAEs, in 10 subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device-related, and there were three explants.

The Genio system has been CE-marked since 2019.

“With the DREAM data, Genio has demonstrated positive efficacy results that OSA patients, having failed traditional medical therapies, have come to expect. Notably, Genio’s unique bilateral stimulation provides the potential for improved outcomes for a wider spectrum of OSA patients. I am excited that Nyxoah and Genio are working towards expanding options and advancing [hypoglossal nerve stimulation system] therapy for OSA, and I look forward to offering it to my patients upon FDA approval,” says B Tucker Woodson, MD, chief, professor at Medical College of Wisconsin and principal investigator of the DREAM study, in a release.

Olivier Taelman, Nyxoah’s chief executive officer, adds in a release, “I am excited to report the positive DREAM results, as they pave the way for Genio to shift the OSA treatment paradigm in the US. With Genio’s patient centric design, strong clinical data, and commercial learnings from Europe, we are confident Nyxoah can become a leading OSA company.” “

Nyxoah is finalizing the fourth and final module submission in the premarket approval application to submit for US Food and Drug Administration approval.