NES ZIONA, Israel—Clinical-stage immunotherapy company Enlivex Therapeutics Ltd. announced today that an investigator-initiated multi-center Phase 2 clinical trial of Allocetra in COVID-19 patients has commenced.
According to a video on Enlivex’s website, “This novel therapy uses the body’s own natural regulation mechanisms without suppressing the immune system. With Allocetra, billions of closely concentrated early apoptotic cells are infused into the patient’s bloodstream. This causes the macrophages and dendritic cells to feed on the Allocetra cells, thus releasing fewer and fewer cytokine alert signals, until the immune system is rebalanced to its normal state.”
“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 1b clinical trial of Allocetra in sepsis patients.
“Therefore, based on compelling preliminary results from the Phase 1b trial that demonstrated safety and an indication of efficacy of Allocetra 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,” van Heerden continued. “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.”
The COVID-19 study is a multi-center investigator-initiated, Phase 2 clinical trial which is expected to recruit up to five patients in each participating center. The trial is designed to assess Allocetra 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 serving as the co-primary study endpoints.
“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 Allocetra translate to COVID-19 patients with similar underlying pathologies,” added Prof. Dror Mevorach, M.D., chief scientific and medical officer of Enlivex. “Further, the scientific insights that could be gained from this study may facilitate the development of other COVID-19 therapies, as well as Allocetra-based treatment plans for diseases in addition to sepsis.”
The COVID-19 study is expected to run independently of Enlivex’s currently planned Phase 2b clinical trial of Allocetra for the treatment of sepsis. The Phase 2b trial is expected to commence in the fourth quarter of 2020.
Earlier in April, Enlivex announced that the company was selected by the Israel Innovation Authority (IIA) to receive a non-dilutive grant of approximately $1.5 million for the period through the first quarter of 2021 for Enlivex’s planned COVID-19 and sepsis clinical programs. Enlivex has received approximately $4.31 million in grants from the IIA for Enlivex’s historical clinical trials and development.
The IIA is an independent, publicly funded agency charged with fostering the development of industrial R&D within Israel. The agency provides non-dilutive grants that become repayable only through royalties from future sales of products developed with the IIA’s support. Repayment, if any, is limited to the original grant amount plus interest.