Announcement: Commencement of Domestic Phase II Clinical Trial of Janus Kinase Inhibitor "ROH-201"
Mar 8, 2021
ROHTO Pharmaceutical Co., Ltd. (Head office: Osaka, hereinafter referred to as "ROHTO Pharmaceutical") has initiated the early-phase Phase II clinical trial of Janus Kinase inhibitor (JAK: Janus Kinase inhibitor), originally created by Japan Tobacco Inc. (Head office: Tokyo, hereinafter referred to as "JT Inc."), and known by the generic name "Delgocitinib," under our development code ROH-201 (hereinafter referred to as "the product").
Janus Kinase is a type of tyrosine kinase within cells, playing a crucial role in immune signal transduction within cells. The product is expected to improve ocular diseases by inhibiting this function, thereby suppressing excessive activation of the immune response. Safety has been confirmed in non-clinical trials as well as in Phase I trials involving healthy adults. Building upon these trial results, the early-phase Phase II trial will evaluate the effectiveness and safety of the product in dry eye patients, including those with Sjögren's syndrome.
JT Inc. received approval for Delgocitinib as a topical ointment for atopic dermatitis and has been advancing its development since January 2020. ROHTO Pharmaceutical, on the other hand, entered into a licensing agreement with JT Inc. in March 2018 and has been developing the product for the treatment of ophthalmic conditions.
Glossary
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- Sjogren's syndrome
- Sjögren's Syndrome: An autoimmune disease characterized by organ-specific symptoms resulting from an imbalance in the immune system, affecting organs such as the tear and salivary glands. In the field of ophthalmology, it is known to worsen due to impairment of the tear glands, leading to dry eye symptoms.
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- Tyrosine Kinase
- A group of enzymes that add phosphate groups to the amino acid tyrosine, which is a component of proteins. They play a vital role in cell proliferation, survival, development, and differentiation and are a collective term for enzymes that play a crucial role in immune signal transduction within cells.
About JT Inc
JT Inc. is a global tobacco manufacturer, with its products being sold in over 130 countries and regions. In addition, the company is engaged in pharmaceutical and processed food businesses, conducting various business activities. JT Inc. primarily leads research and development in the areas of "sugar and lipid metabolism," "immunity and inflammation," and "viruses," with its subsidiary Torii Pharmaceutical Co., Ltd. responsible for manufacturing and sales functions in Japan.
For more information, please visit. https://www.jti.co.jp/