Levosimendan – Phase 3
Levosimendan is under development in North America for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome (LCOS).
The FDA has granted Fast Track status for levosimendan and has agreed to our Phase 3 clinical trial protocol under a Special Protocol Assessment (SPA). The FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.
The Phase 3 clinical trial will study if levosimendan administered before and during surgery will reduce the incidence of morbidity and mortality in cardiac surgery patients at risk of LCOS. There is substantial scientific evidence for the use of levosimendan in cardiovascular surgery, with over 25 published articles in peer reviewed journals and evidence of mortality reduction in some cardiac surgery trials of more than 50%.
Levosimendan – Phase 2
Tenax Therapeutics is collaborating with Imperial College London on the LeoPARDS trial.
We have provided supplemental funding to support the accelerated enrollment and completion of the ongoing LeoPARDS Trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis) awarded by the Efficacy and Mechanism Evaluation (EME) Programme and funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.
The LeoPARDS trial is designed to determine whether levosimendan reduces the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as evaluate its safety profile. Septic shock represents an area of very high unmet medical need, as the condition is associated with high mortality, morbidity and critical care costs. Given the limited treatment options that exist and the prior research data regarding the potential benefits of levosimendan in septic shock patients, the EME Programme awarded funding of the LeoPARDS trial, which will be led by Imperial College London.