Notice of Commencement of Domestic Phase I Clinical Trial for Ophthalmic Therapeutic Agent "ROH-202"
Mar 28, 2022
ROHTO Pharmaceutical Co., Ltd. (Head office: Osaka, hereinafter referred to as "ROHTO Pharmaceutical") entered into a licensing agreement with D. Western Therapeutics Institute, Inc. (hereinafter referred to as "DWTI") for the ophthalmic therapeutic agent "DW-1001" (hereinafter referred to as "the compound") in December 2019. Under the development code of our company, ROH-202 (hereinafter referred to as "the compound"), we have been conducting non-clinical trials aimed at developing it as a therapeutic drug in the field of ophthalmology.
We are pleased to announce that preparations for the domestic Phase I clinical trial (hereinafter referred to as "the trial") have been completed, and we have initiated the trial.
The compound is being developed as a treatment for specific ophthalmic diseases, using a compound that has already been marketed for other indications.DWTI introduced the rights for Japan from a British company in 2015 and has been conducting studies on formulation, among other considerations.
Based on the results of previous non-clinical trials, the compound's effectiveness and safety in the non-clinical phase have been confirmed. Therefore, in this trial, we will proceed to confirm the safety and pharmacokinetics of the compound in humans.
We are considering entering the medical pharmaceuticals business and continue to advance various research initiatives in the field of ophthalmology.
In the future, we will provide products and services that contribute to the eye health of people and aim to be of service in the field of ophthalmology.
The impact of this agreement on the current fiscal year's performance is expected to be minimal.
||D. Western Therapeutics Institute, Inc.
||1-18-11, Nishiki, Naka-ku, Nagoya-shi, Aichi, Japan
||President & CEO Yuichi Hidaka
||Discovery and Development of new drugs
||JPY 573 million (as of December 31, 2021)