Terumo Blood and Cell Technologies collaborates with Eliaz Therapeutics in the development and commercialization of a novel therapeutic apheresis treatment for acute kidney injury (AKI)

Combination of apheresis and Galectin-3 (Gal-3) expertise is expected to result in potential therapeutic option for unmet medical needs

Lakewood, Colorado, US, and Santa Rosa, California, US, July 26, 2022 – Acute kidney injury (AKI) and sepsis-induced acute kidney injury (S-AKI) are life-threatening conditions, with many patients dying and others left with long-term kidney damage requiring lifelong dialysis and resulting in early death.

Terumo Blood and Cell Technologies (Terumo), a medical technology company, and Eliaz Therapeutics Inc. (ETI), a medical device company, today announced an exclusive collaboration to help combat AKI and S-AKI by focusing on the selective removal of an upstream inflammatory protein called Galectin-3 (Gal-3) from blood plasma.

The in-hospital mortality rate for patients with AKI has been estimated at 20 percent to 25 percent, [1] while critically ill patients with dialysis-requiring AKI have mortality rates exceeding 50 percent.[2] Patients who survive an episode of AKI face a lifelong increased risk of chronic kidney disease (CKD), end-stage renal disease (ESRD), cardiovascular events and reduced quality of life. Treatment for AKI/S-AKI is primarily supportive as no therapeutic modalities have shown efficacy.[3] 

Terumo and ETI will initially conduct studies on large animals followed by human clinical trials. Large animal studies are scheduled to start later this year. The collaboration will use Terumo's Spectra Optia(R) Apheresis System with ETI's novel XGal-3(R) column that is designed to selectively remove Gal-3 from blood plasma. XGal-3 is being developed as a platform technology. XGal-3 will be initially tested in AKI and S-AKI.

Terumo Blood and Cell Technologies specializes in a portfolio of technology, software and services for blood component collection, therapeutic apheresis and cellular technologies. The company has other collaborations that use its Spectra Optia system with other columns that are designed for triple-negative breast cancer and COVID-19. The company focuses on innovation and development and spends three times the industry average on this part of the business.

"Over 13 million people globally are affected by AKI, with nearly 2 million lives lost every year.[4] This collaboration leverages the widely available Spectra Optia platform to bring the XGal-3 treatment to patients worldwide," says Veerle d'Haenens, General Manager, Therapeutic Systems, Terumo Blood and Cell Technologies.

In the US alone, AKI and S-AKI affect 4 million people with annual healthcare costs of up to USD 24 billion. Patients who require dialysis face reduced quality of life, while each hospitalization can incur bills totaling USD 42,000 per incident.[5] Current therapeutic options are limited.

"This collaboration will enable us to support the advancement of the XGal-3 device," says Isaac Eliaz, MD, founder and chief executive officer of ETI. "The XGal-3 column device is designed to improve health outcomes for critically ill patients and reduce the incidence of chronic kidney disease and hospital mortality, while potentially reducing the need for dialysis and shortening intensive care stays. Working with Terumo Blood and Cell Technologies could bring broad availability of this therapy to the global marketplace."

ETI recently received its second grant from the National Institutes of Health (NIH). The SBIR-II USD 1.7 million grant will focus on large animal safety studies of the XGal-3 column device, allowing ETI to proceed with clinical trials in sepsis and S-AKI patients. ETI will use Terumo's Spectra Optia in both the large animal studies and human clinical trials. ETI plans to report results from the human clinical trial in approximately three years.

Gal-3 is postulated to be a mediator and driver of inflammation in a wide range of acute and chronic conditions. Increased plasma Gal-3 levels are associated with more severe AKI and sepsis development in critically ill patients.[6] In turn, blocking of Gal-3 has significantly decreased AKI rates and increased survival in animal models.[7]

[1] Lewington AJ, Cerdá J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. 2013;84(3):457-467. doi:10.1038/ki.2013.153/ 

[2] Selby, NM, Kolhe, NV, McIntyre CW, et al. Defining the cause of death in hospitalised patients with Acute Kidney Injury. PLOS ONE. Published November 2, 2012. doi: 10.1371/journal.pone.0048580

[3] Paweena S, Cruz DN, Cerda J, et al. World incidence of AKI: a meta-analysis. CJASN. 2013;8(9):1482-1493. doi: 10.2215/CJN.00710113

[4] Mehta RL, Cerdá J, Burdmann EA, et al. International Society of Nephrology's 0by25 initiative for acute kidney injury (zero preventable deaths by 2025): a human rights case for nephrology. Lancet. 2015; 385:2616-2643. doi: 10.1016/S0140-6736(15)60126-X

[5] Silver SA, Chertow GM. The economic consequences of acute kidney injury. Nephron. 2017;137(4):297-301. doi:10.1159/000475607

[6] Boutin L, Legrand M, Sadoune M, et al. Elevated plasma Galectin-3 is associated with major adverse kidney events and death after ICU admission. Crit Care. 2022;26:13. doi: 10.1186/s13054-021-03878-x

[7] Sun H, Jiang H, Eliaz A, Kellum JA, Peng Z, Eliaz I. Galectin-3 in septic acute kidney injury: a translational study. Crit Care. 2021;25(1):109. 2021;25:109. doi:10.1186/s13054-021-03538-0