Results of Phase II Clinical Trials of New Drug Under Development

Tokyo, Japan --- Teijin Pharma Limited, the core company of the Teijin Group's healthcare business, announced today that new topline results from a Phase II clinical trials (Study TMX-049DN-201), showing that TMX-049, which is being developed for the treatment of diabetic kidney disease (DKD) in type 2 diabetes, achieved its primary endpoint for efficacy.

DKD is a progressive chronic kidney disease that develops with diabetes. As the disease progresses and end-stage kidney disease (ESKD) occurs, renal replacement therapy such as dialysis or kidney transplantation is required. DKD has been reported to be the most common cause of dialysis. When chronic kidney disease progresses, and dialysis is initiated, not only does the patient's QOL significantly deteriorate, but the social burden of medical care costs increases. And there is a growing need for treatments that improve chronic kidney disease, including diabetic kidney disease, and suppress the transition to ESKD.

TMX-049 is a novel non-purine type xanthine oxidase inhibitor discovered by Teijin Pharma. It inhibits uric acid production strongly by selectively inhibiting the enzyme, xanthine oxidase.

Study TMX-049DN-201 is a randomized, double-blind, placebo-controlled study in subjects with type 2 diabetes and albuminuria. The primary efficacy outcome of the study was based on comparison of change in log-transformed urinary albumin-to-creatinine ratio in the placebo and TMX-049 groups. As a result, TMX-049 showed a statistically significant improvement compared to the placebo group, achieving the primary endpoint. No new concerns about the safety were observed.

Teijin Pharma will continue to develop TMX-049 as a new treatment for DKD.

About the Teijin Group
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the areas of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has over 170 companies and around 20,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY888.6 billion (USD 8.1 billion) and total assets of JPY 1020.7 billion (USD 9.3 billion) in the fiscal year ending March 31, 2019.

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