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Samsung Bioepis to Initiate Phase 1 Clinical Trial of SB26 Ulinastatin-Fc Fusion Protein

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

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.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company
committed to realizing healthcare that is accessible to everyone.
Through innovations in product development and a firm commitment to
quality, Samsung Bioepis aims to become the world's leading
biopharmaceutical company. Samsung Bioepis continues to advance a broad
pipeline of biosimilar candidates that includes six late-stage
candidates that cover the therapeutic areas of immunology, oncology and
diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics
and Biogen. For more information, please visit:

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