Samsung Bioepis said Monday that it plans to begin a phase 1 clinical study on SB26, an ulinastatin-Fc (UTI-Fc) fusion protein intended to treat severe acute pancreatitis, in the U.S.

SB26, also known as TAK-671, is the first therapeutic candidate in the risk-sharing strategic collaboration agreement between Samsung Bioepis and Takeda to co-develop multiple novel biologic therapies.

The two companies had signed a strategic collaboration agreement to develop new biopharmaceuticals last August.

Under the agreement, Samsung Bioepis’s biopharmaceutical platform and technology will combine with Takeda's capability to develop new drugs, creating synergy through the process, from searching new substances to conducting clinical trials, winning approvals and commercializing them.

The randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study will assess the safety, tolerability and pharmacokinetics of intravenous SB26. The company expects to complete the trials by the third quarter of 2020.

“The upcoming clinical trial marks a major milestone for Samsung Bioepis, as SB26 is set to become the first novel biologic candidate from our company to enter clinical trials,” said Kim Chul, Samsung Bioepis’ senior vice-president and head of clinical sciences division. “While mild acute pancreatitis is more easily treatable, severe acute pancreatitis, which affects approximately 20 percent of patients suffering from acute pancreatitis, can often be fatal.”

As treatment options remain extremely limited, the company expects to leverage the unique strengths of our partnership with Takeda and hope to advance SB26 through clinical trials rapidly, Kim added.

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