Samsung Bioepis and Takeda begin first trial from R&D tie-up

Korea’s Samsung Bioepis has begun clinical development of its first ever novel biologic – a protein intended to treat severe acute pancreatitis.

A joint venture between Samsung and Biogen, Samsung Bioepis has made its name producing biosimilars in the last few years.

But now thanks to a risk-sharing partnership with Japan’s Takeda, Samsung Bioepis is beginning  clinical development of TAK-671, a novel drug that the companies will be the first of several new therapies to emerge from the partnership.

The partnership is based around Takeda’s established drug development operations, and Samsung’s expertise in developing and manufacturing biologic drugs.

The companies signed the deal inn August last year, without revealing financial details, although the companies did say that they will co-fund and collaboratively develop the therapies.

TAK-671, also known as SB26, is an ulinastatin-FC (UTI-Fc) fusion protein, which has already been tested in preclinical trials in monkeys and rats.

The randomised, 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.

Chul Kim, senior vice president and head of clinical sciences division at 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.

“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.”

A glycoprotein that can be isolated from human urine, or synthetically produced, ulinastatin is already used in Japan and Asian countries to treat acute pancreatitis and other diseases.