R-Tech Ueno, Ltd. has announced plans to conduct collaborative research with a group led by Professor Susumu Ishida and Associate Professor Kousuke Noda of the Department of Ophthalmology, Graduate School of Medicine from Hokkaido University. The research is in the application of a new VAP-1 inhibitor (Development Code: RTU-1096), which is under our development for treatment of diabetic retinopathy (DR) and diabetic macular edema.
RTU-1096 is a VAP-1 inhibitor, having an anti-inflammatory and immunomodulatory effect that is currently undergoing a Phase I clinical trial in Japan (Please refer to our press release dated October 20th, 2014). This collaborative research is to conduct an examination at Hokkaido University to verify the therapeutic effect of RTU-1096 on diabetes ophthalmic complications, such as DR and diabetic macular edema. This examination serves to explore the possibility of the clinical application of the VAP-1 inhibitor for treating DR and diabetic macular edema, in preparation for the POC (Proof of Concept) trials in the future, otherwise known as the Early Phase II clinical trials. Going forward, we will further accelerate development of the VAP-1 inhibitor as an innovative treatment, setting diabetic complications of DR and diabetic macular edema as the top priority target disease.
Yukihiko Mashima MD, an ophthalmologist and President of the company, has stated as follows:
"In recent years, the increase of health care costs associated with the growing number of diabetes patients has become a global concern. In Japan, the population of diabetic patients is more than 20 million people, including potential patients, and the patients with diabetic retinopathy—one of the diabetic complications—which accounts for at least 3 million people.
While the population of patients with proliferative DR causing sight loss has decreased, a specific DR that causes edema in the macular region (central retina) resulting in deteriorating vision (diabetic macular edema) is becoming a growing concern among the patients. The current treatment options for diabetic macula edema include photocoagulation, steroid injections (intraocular injection, injection into the Tenon capsule), and vitrectomy. Recently, intraocular injection of an anti-VEGF therapeutic agent has become a mainstream treatment. As recurrence of this condition is persistent, the patients require a high frequency of anti-VEGF injections annually; however, the drug price is extremely high, and that is one of the causes for increased health care costs. Given these situations, many clinical researches among the physician are actively carried out regarding how to reduce the frequency of anti-VEGF therapeutic agent injections by combining them with a photocoagulation and/or steroid injection, while anti-VEGF agent injection is recognized as the preferred treatment. We are planning to find a solution to this problem through this collaborative research. Considering the policy to extend a healthy life, as conducted by Ministry of Health, Labour and Welfare, as well as the perspective of medical economy, it is necessary to proceed with the strategy to suppress the increasing population of visually impaired patients suffering from DR.
Diabetic patients have characteristically increased VAP-1 activity in their blood—considered one of the causes of complications. The VAP-1 inhibitor RTU-1096 is an agent that is First in Class (First-in-Human use) and is expected to exert a therapeutic efficacy by inhibiting VAP-1 activity in the blood. Accordingly, we believe it will be possible to use this inhibitor (oral medicine) in combination with an intraocular injection of an anti-VEGF agent for treatment of diabetic macular edema. We intend to conduct collaborative research with the Department of Ophthalmology, Graduate School of Medicine from Hokkaido University, where basic research and clinical research of DR and age-related macular degeneration are proactively conducted. We will further develop the effective treatment utilizing this inhibitor, and aim to start POC trials (early Phase II clinical trials) mainly at Hokkaido University Hospital."
The above venture will not contribute to any revisions to the earnings forecasts of the second cumulative quarter and the full year previously announced on May 14, 2015.
R-Tech Ueno, Ltd.
Koji Nakamura, +81-3-3596-8011
Business Management Department