Oxygen Biotherapeutics, a pharmaceutical company specializing on critical care products, will partner with Imperial College London to supply additional funding in an ongoing Phase III trial investigating levosimendan in cardiac surgery patients at risk of low cardiac output syndrome (LCOS).
Levosimendan is an intravenous calcium sensitizer developed for patients with acutely decompensated heart failure. The drug was originally discovered and developed by Finnish firm Orion Pharma. Last year, Oxygen acquired the North America rights to develop and market levosimendan.
The funds will be used to speed enrolment and completion of the LeoPARDS Trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis). LeoPARDS seeks to find out whether levosimendan lessens the severity and incidence of acute organ failure in patients who have septic shock. The trial is funded by the Medical Research Council (MRC) through the Efficacy and Mechanism Evaluation (EME) Program and is managed by the National Institute for Health Research (NIHR) as part of the MRC-NIHR partnership. Oxygen agreed to provide $500,000 of supplemental funding for the LeoPARDS trial, which will be conducted by Imperial College London.
Septic shock is a condition associated with high morbidity, mortality, and critical care costs. The life-threatening condition causes blood pressure to fall to very low levels and compromise blood flow to vital organs. Around 40 percent of patients admitted to intensive care units in the UK die of septic shock.
“Early preclinical and clinical studies of levosimendan have demonstrated potentially unique beneficial effects on heart performance and organ perfusion in patients suffering from septic shock, with a differentiated mechanism that could avoid the pitfalls of commonly used adrenaline-like drugs,” said Dr. Anthony Gordon, lead investigator of the LeoPARDS trial, and a critical care physician and septic shock expert at Imperial College London. Dr. Gordon thanked Oxygen for the additional funds which will help enroll patients faster in the trial.
John Kelley, CEO of Oxygen Biotherapeutics, said that the company is pleased to support the Phase III trial. Kelley added, “While our focus remains on our upcoming Phase 3 trial in cardiac surgery patients at risk of developing LCOS, we are currently monitoring a number of ongoing trials that are designed to evaluate levosimendan in indications such as high risk non-cardiac surgery, acute kidney injury, and acute respiratory failure, which could all represent attractive areas for further development to help patients with critical care conditions of high unmet need.”