University of New Mexico has enrolled a patient in a clinical trial involving a novel investigational drug originally developed for acute breathing and kidney problems by driving down life-threatening inflammation in the body. Developed by Massachusetts-based Sentien Biotechnologies, the investigational product is known as SBI-101. This clinical trial is investigating the safety and tolerability of SB-101 in COVID-19 subjects with acute kidney injury (AKI).
The Medical Problem
Many may not realize that COVID-19 can be often associated with kidney issues ranging from presence of proteinuria and haematuria to acute kidney injury (AKI) requiring renal replacement therapy. This condition is associated with a high mortality rate and serves as an independent risk factor associated with “all-cause in-hospital death in a patients with COVID-19” as explained by a group of researchers led by a corresponding author, John A. Kellum, Department of Critical Care Medicine, Center for Critical Care Nephrology, University of Pittsburgh. See their published manuscript in Nature.
What is SB-101?
A regenerative-based therapy, this is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. More on the investigational product can be reviewed here.
According to Clinicaltrials.gov, the University of New Mexico is the only trial site organization participating in this early stage Phase 1/2 clinical trial (NCT04445220). This study assesses the safety and tolerability of SB1-101 in COVID-19 patients with acute kidney injury. SB1-101 is integrated into the renal replacement circuit as patients are treated for up to 24 hours. Involving 22 participants the study commenced this month and runs to July 2021.
Principal Investigator Point of View
Pedro Teixeria is an assistant professor with the Department of Internal Medicine at UNM Hospital and recently commented for local media KRQE, “We’re using stem cell therapy to counteract an overactive immune system that is definitely part of the COVID-19 disease.”
Founded in 2008, Sentien Biotechnologies has raised over $15 million in venture capital funds. The company is organized around investigational product SB1-101 and its pipeline focuses on Acute Kidney Injury as well as Chronic Kidney Disease. They also investigate Acute Inflammation-mediated disease and most recently, of course, COVID-19 related conditions.
The company’s intellectual property is rooted in pioneering cell therapy research undertaken by Biju Parekkadan, PhD, at the Massachusetts Institute of Technology and the Center for Engineering and Medicine at Massachusetts General Hospital. Upon understanding the potential of his breakthrough MSC therapy methods, Dr. Parakkadan teamed with Brian Miller to co-found Sentien Biotechnologies to pursue development for clinical use.
The company was awarded dilutive funding from the NIH Small Business Innovation Research (SBIR) program and in 2017 closed a $12 million venture capital A round including participation from Boehringer Ingelheim, the world’s largest privately held biopharmaceutical company.
Pedro Teixeria, MD, assistant professor with the Department of Internal Medicine at UNM Hospital