Samsung Bioepis to start clinical trials of first new drug candidate with Takeda Pharmaceutical

Samsung Bioepis said Monday that it plans to soon start phase 1 clinical trials for its first new drug candidate in development with Japan’s Takeda Pharmaceutical, setting a fresh milestone in the South Korean drugmaker’s push into new drug development.

The therapeutic candidate, SB26, also known as TAK-671, is an ulinastatin-Fc fusion protein to treat severe acute pancreatitis. It is the first result of the new drug development collaboration partnership signed by the two companies in August 2017.

The upcoming clinical trials will be held in the US only, a Samsung Bioepis spokesperson confirmed, though the exact start date for the trials remain undisclosed.

The study -- randomized, double-blind, placebo-controlled and involving single and multiple dose escalation -- will assess the safety, tolerability and pharmacokinetics of intravenous injections of SB26 in healthy volunteers.

The results of the study are expected in the third quarter of 2020, Samsung Bioepis said.

“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,” Kim Chul, senior vice president and head of the clinical sciences division at Samsung Bioepis, said in a statement.

“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 percent 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.”

Pancreatitis is a condition caused by an inflammation in the pancreas, an organ located in the upper abdomen behind the stomach that produces digestive enzymes and hormones. Pancreatitis can either be acute, occurring suddenly and potentially being life-threatening, or chronic, lingering over the course of several years.

Samsung Bioepis was founded in 2012 as a joint venture between Samsung BioLogics and US-based Biogen, focusing primarily on developing biosimilars -- lower-cost copies of live cell biologic drugs whose patents have expired -- for global markets.

Last year, Samsung Bioepis forayed into the realm of new drug development through a “risk-sharing partnership” that combines Bioepis’ speedy biologics development platform with Takeda’s drug development expertise to co-fund and collaboratively develop innovative therapies.

By Sohn Ji-young (jys@heraldcorp.com)