Sentien Biotechnologies said this week it received an Investigational New Drug approval for its SBI-101 drug-device combination product meant for treating individuals with acute kidney injury.
The multi-center, Phase 1/2 trial will be the the 1st for the company, and will examine its platform which uses a blood filtering device containing mesenchymal stromal cells for the controlled, sustained delivery of MSC secreted factors.
“This marks a very significant milestone for our company as we move our lead product into the clinic. 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,” CEO Brian Miller said in a press release.
The 24-patient trial is slated to be a randomized, controlled, multi-dose study in patients with acute kidney injury receiving continuous renal replacement therapy. The study’s primary objective will be to evaluate the safety and tolerability of the drug-device combo, while secondary endpoints will examine efficacy.
Patient enrollment is planned for the 2nd quarter of 2017 and expected to continue through 2018, the company said.
Sentien said earlier this month it closed a $12 million Series A financing round, co-led by Boehringer-Ingelheim Venture Fund USA, Inc. and BioInnovation Capital. Chiesi Ventures, MBL Venture Capital Co. and Mass Medical Angels also contributed to the round.