■Kubota Pharmaceutical Holdings＜4596＞ Company Overview
1. Company history
Dr. Kubota Ryo (Kubota), a researcher and ophthalmologist, established the former Acucera Inc., in 2002 in Seattle, USA, for the purpose of developing pharmaceuticals and medical devices specialized in the field of ophthalmology. After being listed as a foreign stock on the Tokyo Stock Exchange in 2014/2, the Japanese corporation was converted into a holding company as Kubota Pharmaceutical Holdings Co., Ltd. by a triangular merger method in 2016/12, and re-listed as TSE Mothers domestic stock (the former Acucella Inc., was delisted at the end of November of the same year). Currently, it is listed on the Tokyo Stock Exchange Growth Market.
Since its establishment, it has established a corporate philosophy of “contributing to society by bringing innovative therapeutic agents and medical technology to eye diseases,” and has been carrying out business activities. Development of the therapeutic drug candidate “emixstat hydrochloride” using visual cycle modulation technology* began in 2006, and a joint development and sales agreement was concluded with Otsuka Pharmaceutical Co., Ltd. (group company of Otsuka Holdings ＜4578＞) in 2008 targeting dry age-related macular degeneration with cartographic atrophy, but the agreement was terminated in response to the results of the Phase 2 late/phase 3 clinical trial announced in 2016/5. Also, phase 3 clinical trials targeting Stargard disease, which is a hereditary retinal disease, have been proceeding, but it was announced in 2022/8 that no significant differences were obtained in the main evaluation items. However, since effects on suppressing progression of symptoms were confirmed in the group of subjects in the initial symptom stage from subsequent data analysis, development strategies are being re-examined.
* Visual cycle modulation technology: A treatment technology that is expected to reduce harmful by-products accumulated in the retina by the visual cycle (a mechanism by which photons are converted into electrical signals in the retina at the back of the eyeball), reduce retinal damage due to oxidative stress, and protect the retina from light damage. The effect of “emixstat hydrochloride” selectively inhibits an enzyme called RPE65, which shows an important function in the visual cycle, has been confirmed from clinical trial results.
As a medical device development pipeline, in addition to the wearable myopia device “Kubota Glass,” which is expected to suppress the progression or amelioration effect of myopia, there is also a remote ophthalmology monitoring device “eyeMO” that can measure the state of the retina themselves at home for retinal diseases such as age-related macular degeneration. “Kubota Glass” was soft-launched in the US from 2022/6 and in Japan from August of the same year, respectively, and sales activities are currently being carried out in Japan. Furthermore, in 2019/3, a development contract was signed with TRISH*, an organization related to NASA in order to proceed with the development of an ultra-compact ophthalmology diagnostic device to monitor the retinal health status of astronauts during astronauts during astronauts. Development of the first phase ended in 2020/2 and received good reviews, but after that, while NASA's budget was being reviewed due to a change of administration, the project continued to be interrupted.
*TRISH (Translational Research Institute for Space Health): A consortium that funds innovative technology to protect and maintain the mental and physical health of astronauts in NASA's deep space missions through a partnership through a joint agreement with NASA.
(Author: FISCO Visiting Analyst Joe Sato)