Samsung Bioepis To Initiate Phase 1 Trial Of SB26 Ulinastatin-Fc Fusion Protein
(RTTNews.com) - Samsung Bioepis Co., Ltd. said it will soon begin a Phase 1 study to evaluate SB26 in healthy volunteers. SB26, also known as TAK-671, is a ulinastatin-Fc (UTI-Fc) fusion protein intended to treat severe acute pancreatitis. Non-clinical GLP safety studies performed in monkeys and rats supported early human studies with SB26.
The randomized, double-blind, placebo-controlled, single and multiple dose escalation Phase 1 study is designed to assess the safety, tolerability and pharmacokinetics of intravenous SB26 in healthy volunteers. Results of the Phase 1 study are expected in the third quarter of 2020.
SB26 is the first therapeutic candidate in the risk-sharing strategic collaboration agreement between Samsung Bioepis and Takeda Pharmaceutical Company Limited , which brings together Samsung Bioepis' agile biologics development platform with Takeda's best-in-class experts in drug development to co-fund and collaboratively develop innovative therapies representing meaningful value to patients who need them.
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