Enlivex Therapeutics Ltd. announced that an investigator-initiated multi-center Phase II clinical trial of AllocetraTM (formerly referred to as off-the-shelf AllocetraTM) in COVID-19 patients has commenced.
“While work investigating the exact pathophysiology of COVID-19 is ongoing, recent publications have described the complications related to the virally induced COVID-19 disease as associated with organ dysfunction and cytokine storms, which are markedly similar to those observed in septic patients in the ICU,” said Prof. Vernon van Heerden, Head of the Critical Care Medicine Unit at Hadassah Hospital in Israel, and the lead investigator of both the COVID-19 trial and a recently-completed Phase Ib clinical trial of AllocetraTM in sepsis patients. “Therefore, based on compelling preliminary results from the Phase Ib trial that demonstrated safety and an indication of efficacy of AllocetraTM in patients with severe sepsis admitted to the ICU, Enlivex’s product candidate may potentially be beneficial for COVID-19 patients with moderate to severe symptoms. We expect that the current study will build on these recent findings by evaluating the potential relationship between cytokine storms and COVID-19-induced organ failure.”
Prof. Dror Mevorach, M.D., Chief Scientific and Medical Officer of Enlivex, added “This newly initiated study represents a unique opportunity for Enlivex to contribute towards efforts aimed at combating the ongoing global COVID-19 pandemic. We are eager to learn if the initial positive results seen in sepsis patients treated with AllocetraTM translate to COVID-19 patients with similar underlying pathologies. Further, the scientific insights that could be gained from this study may facilitate the development of other COVID-19 therapies, as well as AllocetraTM-based treatment plans for diseases in addition to sepsis.”
The COVID-19 study is a multi-center investigator-initiated, Phase II clinical trial. The trial is expected to recruit up to five patients in each participating center and is designed to assess AllocetraTM in combination with standard of care therapy in patients with COVID-19 associated lung dysfunction. Safety, tolerability, cytokine profile and efficacy parameters will be evaluated, with change in PaO2/FiO2 ratio number and severity of adverse events and serious adverse events serving as the co-primary study endpoints.
The COVID-19 study is expected to run independently of Enlivex’s currently planned Phase IIb clinical trial of AllocetraTM for the treatment of sepsis. The planned Phase IIb trial will be a controlled, randomized study that is expected to commence in the fourth quarter of 2020.