Nyxoah SA has 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 pivotal trial being conducted under an investigational device exemption (IDE) and is designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (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 (AHI) responder rate, per the Sher criteria, and the Oxygen Desaturation Index (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 (PSG). More information regarding the study can be found in section 1.5.4 of the Company’s annual report regarding financial year 2022, which can be found on the Company’s website using the following link: Nyxoah Annual Report 2022 EN.pdf.
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% (p=0.002), and 82 subjects were determined to be ODI responders, resulting in an ODI 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 ten subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device-related, and there were three explants.
“DREAM is a pivotal, multicenter, international study of Genio, a next-generation HGNS technology offering patients bi-lateral stimulation with a non-implanted battery solution powered and controlled by a wearable. 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 HGNS therapy for OSA, and I look forward to offering it to my patients upon FDA approval,” commented B Tucker Woodson, MD, Chief, Professor – Medical College of Wisconsin and Principal Investigator of the DREAM study.”
“I am excited to report the positive DREAM results as they pave the way for Genio to shift the OSA treatment paradigm in the U.S. With Genio’s patient-centric design, strong clinical data and commercial learnings from Europe, we are confident Nyxoah can become a leading OSA company,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We are finalizing the fourth and final module submission in the PMA application, and I look forward to launching Genio in the U.S., pending FDA approval.”
Source: Nyxoah
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