Sedana Medical finishes US clinical program patient recruitment

Sedana Medical AB (publ) has successfully completed the recruitment of all 235 patients for its phase III clinical trial, INSPiRE-ICU 2, in the United States. This trial marks the conclusion of Sedana Medical's clinical studies in the U.S. Earlier this year, the company also concluded enrollment for its parallel trial, INSPiRE-ICU 1. Sedana Medical anticipates that the topline results for both studies will be available in the latter half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025.

Peter Sackey, Chief Medical Officer of Sedana Medical, expressed enthusiasm about the completion of the U.S. trials. He highlighted the rewarding experience of collaborating with leading clinical investigators from esteemed academic centers such as Columbia University and the Harvard-affiliated Beth Israel Deaconess Medical Center. The participation of these sites has generated significant interest in the potential application of inhaled sedation in U.S. medical practice.

According to Sackey, the company is now entering a crucial phase of final monitoring, data cleaning, and preparing the data for statistical analysis. Meanwhile, long-term outcomes at three and six months are being collected by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. This parallel approach is expected to yield topline results for the 30-day outcomes of both studies before the end of the year, facilitating a prompt regulatory submission in early 2025.

The trials are investigating the use of isoflurane, an inhaled sedative commonly used in general anesthesia during surgery, for its potential benefits in ICU patients. Jeremy Beitler, MD, MPH, a Senior Lead Investigator for the INSPiRE-ICU 2 study at Columbia University, expressed excitement over the completion of patient enrollment and eagerly awaits results that could support the use of isoflurane as a sedative for ventilator-dependent ICU patients in the U.S.

Johannes Doll, President and CEO of Sedana Medical, emphasized the significance of completing the clinical program. He extended gratitude to all clinical trial sites, partners, and the Sedana Medical team for their contributions. Doll highlighted the importance of the collaboration with top U.S. hospitals in moving towards making inhaled sedation available to intensive care patients.

The INSPiRE-ICU 1 and 2 trials are designed to confirm the efficacy and safety of isoflurane sedation using Sedana Medical's specialized device, Sedaconda ACD. The primary endpoint of the trials is to measure the proportion of time patients spend at an adequate depth of sedation compared to intravenous sedation with propofol. Secondary endpoints include opioid use, time to wake-up, cognitive recovery, and spontaneous breathing. The first patient was enrolled in April 2022, and 31 renowned U.S. clinics are participating in the trials. The design of these U.S. studies is akin to the successful Sedaconda study (SED001) conducted in Europe from 2017 to 2019, which led to market approval in 2021.

Sedana Medical is a medtech and pharmaceutical company specializing in inhaled sedation for mechanically ventilated patients in intensive care. The company operates directly in several European countries and works with external distributors in other regions. Founded in 2005, Sedana Medical is listed on Nasdaq Stockholm and is headquartered in Stockholm, Sweden.