Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the first patient has been enrolled in the company’s US clinical studies.
The two identical Phase III studies, INSPiRE-ICU 1 and 2, aim to confirm the efficacy and safety of inhaled sedation with isoflurane delivered via Sedaconda ACD and are expected to lead to a new drug application (NDA) filing at the US Food and Drug Administration (FDA) in the US.
The studies will compare the safety and efficacy of sedation with inhaled isoflurane delivered via Sedaconda ACD or intravenous propofol in adult mechanically ventilated ICU patients.
“Our clinical trials INSPiRE-ICU 1 and 2 are strategically significant as they will form the basis of our NDA submission in the United States, which represents our largest commercial opportunity. We are excited about reaching this important milestone and are looking forward to bringing our products to intensive care patients in the US”said Johannes Doll, CEO of Sedana Medical.
Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane) for sedation of mechanically ventilated intensive care patients in the United States.
Assuming rapid enrolment of patients and successful trials, Sedana Medical continues to expect the NDA submission in 2024 and a launch in early 2025.
“It is very rewarding to collaborate with many of the top academic institutions across the US. There is a lot of excitement among US Key opinion leaders within sedation and mechanical ventilation, given the promising European data and the trial being the first exposure to the therapy in the US. Besides supporting our US registration process, the INSPiRE-ICU studies will shed light on clinically relevant aspects of inhaled sedation that can bring a paradigm shift to sedation in the ICU in the US.”said Peter Sackey, Chief Medical Officer of Sedana Medical.
About the studies INSPiRE-ICU 1 and INSPiRE-ICU 2 (SED003 and SED004)
The INSPiRE-ICU (Inhaled Sedation vs Propofol in Respiratory failure) studies are two identical phase III studies aiming to confirm the efficacy and safety of inhaled isoflurane, delivered via the Sedaconda ACD, for the sedation of adult mechanically ventilated ICU patients, in comparison to intravenous infusion of propofol.
The studies will enrol a total of 470 adult patients across 25-30 sites in the US. Patient enrolment is expected to be completed in 2023.
The primary endpoint is the proportion of time spent within the target range of sedation depth in absence of rescue sedation, as assessed according to the Richmond Agitation Sedation Scale (RASS).
In addition, the studies will investigate several secondary endpoints, including the use of opioids, the wake-up time, the cognitive recovery after end of sedation, and the spontaneous breathing effort. The assessments will be performed by blinded assessors to meet the requirements of the FDA.
About Sedana Medical