Nyxoah announces DREAM study meets primary endpoints

Nyxoah announced the DREAM U.S. pivotal study achieved a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and ODI responder rate, both on an ITT basis. The DREAM study is a trial, being conducted under an investigational device exemption and is designed to support the marketing authorization of the Genio hypoglossal nerve stimulation system, or HGNS, in the United States. This multicenter, prospective, open-label, interventional study enrolled 115 patients and has co-primary efficacy endpoints of the Apnea-Hypopnea Index, or AHI, responder rate, per the Sher criteria, and the Oxygen Desaturation Index, or ODI, 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, or PSG. Study participants entered the DREAM study with a mean AHI of 28.0, mean ODI of 27.0 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%, and 82 subjects were determined to be ODI responders, resulting in an ODI responder rate of 71.3%. 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 ten subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device related and there were three explants.