Sentien Announces Active IND for SBI-101 in Patients with Acute Kidney Injury
At the Stem Cell Summit on 4/7, Sentien CEO Brian Miller announced that the company’s investigational new drug (IND) application for SBI-101 for the treatment of adult patients with acute kidney injury (AKI) is now active. The IND, which the company has filed in the United States with the Food and Drug Administration, enables Sentien to initiate a multi-center, Phase 1/2 trial to evaluate the administration of SBI-101 in this patient population. The trial will be the first clinical program for Sentien Biotechnologies.
“This marks a very significant milestone for our company as we move our lead product into the clinic,” said Mr. Miller. “We are motivated and excited by the opportunity to advance SBI-101 into the clinic to treat patients with severe AKI, which represents a significant unmet medical need.”
SBI-101, Sentien’s investigational product candidate, is a platform treatment modality that combines mesenchymal stromal cells (MSCs) within a blood-filtration device, allowing for controlled, sustained delivery of MSC secreted factors.
The trial will be a randomized, controlled, multi-dose Phase 1/2 study in patients with acute kidney injury receiving continuous renal replacement therapy. The primary objective of this trial is to evaluate the safety and tolerability of SBI-101 in patients with acute kidney injury. Endpoints for SBI-101 efficacy will also be evaluated. Study enrollment is slated to begin in the second quarter of 2017 and is expected to continue into 2018, with an estimated enrollment of 24 patients.