STOCKHOLM, April 25, 2024 /PRNewswire/ -- Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 1 phase III clinical trial in the United States. Concurrently, the identical INSPiRE-ICU 2 trial is nearing completion, with 23 of 235 randomized patients remaining. The company anticipates topline results from both trials in the second half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025.

"The completion of the INSPiRE-ICU 1 study marks a true milestone for Sedana Medical. Launching the randomized controlled multicenter studies across the large and diverse US healthcare landscape, in mixed surgical and medical ICUs with a different staffing and workflow compared to Europe, has been exciting. There is a lot of enthusiasm and interest in using inhaled sedation in US practice, which we hope will be possible soon", said Peter Sackey, Chief Medical Officer of Sedana Medical.

Peter Sackey further elaborated: "Once the 30-day follow-up of all patients is complete, we will enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months will be collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results in the autumn of this year and a swift regulatory submission in Q1, 2025".

"Working on these trials from initial design to implementation and completion has been very rewarding and has brought together many experienced clinical researchers in critical care across the US. We, and the clinicians at the bedside, are eager to see inhaled sedation available also in the US", said Christopher Hughes, Professor of Anesthesiology at Vanderbilt University Medical Center and Senior Lead Investigator for the INSPiRE-ICU 1 study.

Johannes Doll, President and CEO of Sedana Medical, expressed gratitude, stating: "I would like to sincerely thank all our clinical trial sites, partners, and the Sedana Medical team for this significant achievement. It makes me very proud that we have been able to convene this exceptional group of intensive care teams from some of the most prominent US hospitals. Their advice and support will be invaluable as we work towards making the benefits of inhaled sedation accessible to patients in the United States."

INSPiRE-ICU 1 and 2 are two identical randomized phase III trials, aiming to confirm the efficacy and safety for sedation with isoflurane delivered via Sedana Medical's unique medical device Sedaconda ACD. The primary endpoint is the proportion of time spent at adequate depth of sedation, compared with intravenous sedation using propofol. In addition, several important secondary endpoints are being studied, including opioid use, time to wake-up, cognitive recovery and spontaneous breathing. The first patient was included in April 2022, and 31 highly reputed clinics in the United States are involved in the two trials. The design of the US studies is similar to the Sedaconda study (SED001) successfully performed in Europe in 2017–2019, which resulted in market approval in 2021.