Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints
Nyxoah announces successful results from the DREAM U.S. pivotal study, showing a significant reduction in sleep apnea symptoms with high responder rates and promising safety profile. The study achieved a 70.8% median reduction in the Apnea-Hypopnea Index (AHI) and a 71.3% responder rate in the Oxygen Desaturation Index (ODI) on an intent to treat basis.
The recent announcement by Nyxoah regarding the DREAM U.S. pivotal study highlights the potential for a significant advancement in the treatment of Obstructive Sleep Apnea (OSA). The study's reported responder rates for Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) suggest that the Genio hypoglossal nerve stimulation system (HGNS) could offer a considerable improvement over current therapies. It's important to note that the responder rate is an indicator of the proportion of patients experiencing a clinically meaningful improvement in their condition.
From a medical research perspective, the median 12-month AHI reduction of 70.8% is particularly noteworthy, as AHI is a widely used metric for assessing the severity of OSA. A reduction of this magnitude could have significant implications for patient health outcomes, including reduced risk for cardiovascular and metabolic disorders often associated with OSA. However, while the safety profile is described as favorable, the presence of serious adverse events (SAEs) in 8.7% of subjects, including device-related incidents, warrants a closer look to assess the risk-benefit ratio for potential patients.
The positive outcome of the DREAM study is likely to have a favorable impact on Nyxoah's market positioning and financial performance, especially with the potential FDA approval on the horizon. Investors should consider the size of the OSA market in the United States, which is substantial and growing due to increased awareness and diagnosis rates. The unique bilateral stimulation technology of the Genio system could enable Nyxoah to capture a significant market share, provided that the FDA approval process concludes successfully.
However, the cost of commercialization and the competitive landscape should be taken into account. The company's ability to scale production, manage regulatory hurdles and penetrate the market against established treatments will be critical factors in realizing the potential revenue growth. Additionally, the timing of the FDA approval and the subsequent product launch will be key determinants of financial impact in the short term.
The Genio system's non-implanted battery solution and bilateral stimulation represent a technological innovation in the field of sleep apnea treatment, which may lead to increased adoption rates among patients dissatisfied with or unable to tolerate CPAP devices. The patient-centric design could be a differentiating factor that enhances patient compliance and treatment efficacy.
Market acceptance will depend on several factors, including insurance coverage, healthcare provider endorsement and patient-reported outcomes. The commercial learnings from Europe will be instrumental in shaping the marketing strategy in the U.S. It is also essential to monitor how the competitive dynamics within the OSA treatment landscape evolve, as new technologies and treatments emerge.
03/19/2024 - 04:05 PM
Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints
Reports an Apnea-Hypopnea Index (AHI) responder rate of 63.5% on an intent to treat (ITT) basis (p=0.002) Reports an Oxygen Desaturation Index (ODI) responder rate of 71.3% on an intent to treat (ITT) basis (p<0.001) Median 12-month AHI reduction of 70.8%
Mont-Saint-Guibert, Belgium – March 19, 2024, 9:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today 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.”
Conference call and webcast presentation
Company management will host a conference call to discuss the DREAM results today beginning at 9:30pm CET / 4:30pm ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: DREAM Results Webcast . For those not planning to ask a question of management, the Company recommends listening via the webcast.
If you plan to ask a question, please use the following link: DREAM Results Call . After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.
About Nyxoah
Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.
For more information, please see the Company’s annual report for the financial year 2023 which will be filed on March 20, 2024 and visit http://www.nyxoah.com/ .
Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.
Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; reporting data from Nyxoah’s DREAM U.S. pivotal trial; filing for FDA approval; and entrance to the U.S. market. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
Contact: Nyxoah david.demartino@nyxoah.com
What are the primary endpoints met in the DREAM U.S. pivotal study by Nyxoah?
The primary endpoints met in the DREAM U.S. pivotal study by Nyxoah were a 63.5% AHI responder rate and a 71.3% ODI responder rate on an intent to treat basis.
What was the median 12-month AHI reduction reported in the study?
The study reported a median 12-month AHI reduction of 70.8%.
How many patients were enrolled in the DREAM study conducted by Nyxoah?
The DREAM study conducted by Nyxoah enrolled 115 patients.
What was the AHI responder rate at 12 months in the DREAM study?
At 12 months, the AHI responder rate in the DREAM study was 63.5%.
Who commented on the positive DREAM results and the potential impact of Genio in OSA treatment in the U.S.?
Olivier Taelman, Nyxoah’s Chief Executive Officer, commented on the positive DREAM results and the potential impact of Genio in OSA treatment in the U.S.
