Sedana Medical clinical studies

The Sedaconda study

In 2020, Sedana Medical completed the Sedaconda study (SED001), the largest randomised, controlled, open-label trial performed to date on inhaled sedation in intensive care.

The phase III study aimed to confirm the efficacy and safety of sedation with Sedaconda (isoflurane) delivered via the Sedaconda ACD in mechanically ventilated ICU patients, comparing it to standard sedation with intravenously administered propofol. A total of 301 patients from 24 intensive care clinics in Germany and Slovenia were randomized to either sedation method.

The study successfully reached its primary endpoint, demonstrating Sedaconda’s non-inferiority to intravenous propofol in maintaining an adequate depth of sedation. Additionally, the results showed that sedation with Sedaconda reduced the need for opioids, facilitated spontaneous breathing, and enabled a faster and more predictable awakening. In terms of safety, Sedaconda was well tolerated, with a safety profile consistent with previous findings for isoflurane.

The results were published in The Lancet Respiratory Medicine journal (Meiser et al., 2021) and constituted the basis for Sedana Medical's European marketing approval for Sedaconda for inhaled sedation.

The IsoCOMFORT study

In 2021, Sedana Medical initiated the IsoCOMFORT study (SED002), a paediatric phase III study aiming to investigate whether sedation with Sedaconda (isoflurane) delivered via the Sedaconda ACD, is safe and more effective than intravenously administered midazolam in mechanically ventilated ICU paediatric patients between 3-17 years old.

Currently, midazolam is the only sedation option for children in ICU because propofol is contraindicated due to the risk of serious adverse events. The patients will be sedated for 12–48 hours with either sedation method, and the primary endpoint will be the proportion of time spent at adequate sedation depth.

The study will involve 160 patients from intensive care clinics in Germany, France, Spain, Sweden, and the UK. The results of the study are expected to lead to an approved paediatric indication for inhaled sedation.

Patient enrolment was completed during 2023.

Further information on the study is available at www.clinicaltrials.gov (NCT04684238).

The INSPiRE-ICU 1 & INSPiRE-ICU 2

The INSPiRE-ICU (Inhaled Sedation vs Propofol in Respiratory failure) studies (SED003 and SED004) 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 results of the studies will form the basis of a new drug application (NDA) filing at the US Food and Drug Administration (FDA).

The primary endpoint will be 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 studies will enrol a total of 470 adult patients across 25-30 sites in the US. The first patient was enrolled in April 2022.

Further information on the studies is available at www.clinicaltrials.gov (NCT05312385 for SED003 and NCT05327296 for SED004).

UNITED STATES (US) EXPANDED ACCESS POLICY

Sedana Medical is dedicated to providing products that deliver inhaled sedation for mechanically ventilated patients in Intensive Care Unit settings, with the aim of improving patients’ lives both during and beyond sedation. Our lead product, Sedaconda (isoflurane) delivered via the Sedaconda ACD device system, is approved and marketed in multiple European countries, however its use in the US remains investigational at this time. Sedana Medical is actively pursuing its US development program in an effort to bring this product to US patients and healthcare providers as quickly and efficiently as possible. Phase III clinical trials are currently underway at multiple centers in the US, which are intended to form the basis of a future marketing application to the US Food and Drug Administration (FDA).

The 21^st Century Cares Act, enacted as US law in 2016, requires manufacturers of investigational drugs intended to treat serious diseases or conditions to make publicly available their policy for providing expanded access to such products. Expanded access, also referred to as compassionate use, is a mechanism for enabling the use of an investigational therapy outside of a clinical trial when the primary purpose is to diagnose, prevent or treat a serious condition in patients. This is in contrast to clinical trials, where more comprehensive safety and efficacy data are generally collected.

At Sedana Medical, our investigational efforts and resources remain focused on our current US clinical trials program with the goal of bringing Sedaconda and the Sedaconda ACD-S to the US market. While we fully understand the importance of Expanded Access Programs (EAPs) in certain circumstances, our perspective at this time is that participation in one of our ongoing phase III clinical studies is the most appropriate way for patients in the US to gain access to this investigational therapy. Accordingly, it is currently not available via an EAP in the US. We encourage patients to speak with their health care team about the possibility of participation in a clinical trial of Sedaconda. Additional information regarding the ongoing phase III trials can be found at clinicaltrials.gov (NCT 05312385 or NCT 05327296), or by emailing medinfo@sedanamedical.com or info@sedanamedical.com.

Sedana Medical may revise this policy at any time. Should expanded access to Sedaconda and the Sedaconda ACD-S become available in the future, this web page will be updated accordingly, and appropriate information on how to apply for expanded access will be provided.