Samsung Bioepis Co., Ltd. today announced 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.
“The upcoming clinical trial marks a major milestone for those of us at Samsung Bioepis, as SB26 is set to become the first novel biologic candidate from our company to enter clinical trials,” said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. “Acute pancreatitis remains one of the most common gastrointestinal conditions, affecting more patients every year. While mild acute pancreatitis is more easily treatable, severe acute pancreatitis, which affects approximately 20% of patients suffering from acute pancreatitis, can often be fatal. Unfortunately, treatment options remain extremely limited. By leveraging the unique strengths of our partnership with Takeda, we hope to rapidly advance SB26 through clinical trials.”
SB26 is the first therapeutic candidate in the risk-sharing strategic collaboration agreement between Samsung Bioepis and Takeda Pharmaceutical Company Limited (TSE: 4502), 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.