Emixustat

Kubota Vision Announces Positive Post Hoc Analysis from Phase 3 Clinical Trial of Emixustat in Patients with Stargardt Disease

Retrieved on: 
Monday, October 3, 2022

Kubota Vision Inc. (Kubota Vision), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today positive results from a post hoc analysis of the phase 3 clinical trial of the investigational visual cycle modulator emixustat hydrochloride (emixustat) in patients with Stargardt Disease.

Key Points: 
  • Kubota Vision Inc. (Kubota Vision), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today positive results from a post hoc analysis of the phase 3 clinical trial of the investigational visual cycle modulator emixustat hydrochloride (emixustat) in patients with Stargardt Disease.
  • This analysis determined that emixustat treatment resulted in a 40.8% reduction in lesion progression compared to placebo at Month 24 (p=0.0206, emixustat n=34, placebo n=21).
  • As previously announced in August 2020, the FDA Office of Orphan Products Development (OOPD) awarded Kubota Vision an orphan products clinical trial grant to support this clinical trial.
  • https://www.kubotavision.com/ ; https://www.kubotaholdings.co.jp/en/
    Kubota Vision, the Kubota Vision logo and Kubota are registered trademarks or trademarks of Kubota Vision Inc. or Kubota Pharmaceutical Holdings in various jurisdictions.

Kubota Vision Announces Database Lock for Phase 3 Clinical Trial of Emixustat in Patients with Stargardt Disease and Expected Release of Top-Line Results in August 2022

Retrieved on: 
Wednesday, July 27, 2022

Kubota Vision previously announced that the trial was completed in June 2022, as the last patient underwent their last visit.

Key Points: 
  • Kubota Vision previously announced that the trial was completed in June 2022, as the last patient underwent their last visit.
  • Ryo Kubota, MD, PhD, Chairman, President, and CEO of Kubota Vision Inc., stated, Database lock marks an important step towards being able to report the most important results from our phase 3 trial in Stargardt disease.
  • Kubota Vision is exploring emixustats potential to stop or slow the progression of vision loss in patients diagnosed with Stargardt disease in an ongoing clinical study.
  • https://www.kubotavision.com/ ; https://www.kubotaholdings.co.jp/en/
    Kubota Vision, the Kubota Vision logo and Kubota are registered trademarks or trademarks of Kubota Vision Inc. or Kubota Pharmaceutical Holdings in various jurisdictions.

Kubota Vision Announced End of Phase 3 Clinical Trial of Emixustat in Patients with Stargardt Disease

Retrieved on: 
Friday, June 24, 2022

Kubota Vision Inc. (Kubota Vision), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today the completion of the phase 3 clinical trial investigating emixustat hydrochloride (emixustat) in patients with macular atrophy secondary to Stargardt disease.

Key Points: 
  • Kubota Vision Inc. (Kubota Vision), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today the completion of the phase 3 clinical trial investigating emixustat hydrochloride (emixustat) in patients with macular atrophy secondary to Stargardt disease.
  • Stargardt disease affects less than 150,000 patients in total in the U.S., Europe and Japan where it is recognized as an orphan disease.
  • Kubota Vision is exploring emixustats potential to stop or slow the progression of vision loss in patients diagnosed with Stargardt disease in an ongoing clinical study.
  • https://www.kubotavision.com/ ; https://www.kubotaholdings.co.jp/en/
    Kubota Vision, the Kubota Vision logo and Kubota are registered trademarks or trademarks of Kubota Vision Inc. or Kubota Pharmaceutical Holdings in various jurisdictions.

Opthea Company Secretary Resignation

Retrieved on: 
Tuesday, April 6, 2021

Opthea (ASX:OPT; Nasdaq:OPT) is a biopharmaceutical company developing a novel therapy to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

Key Points: 
  • Opthea (ASX:OPT; Nasdaq:OPT) is a biopharmaceutical company developing a novel therapy to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
  • Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities.
  • Opthea strongly recommends that professional investment advice be sought prior to such investments.
  • The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law.

Kubota Vision Completes Enrollment in the Emixustat Phase 3 Clinical Trial in Patients with Stargardt Disease

Retrieved on: 
Friday, May 1, 2020

Kubota Vision Inc. (Kubota Vision), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today that the company has completed subject enrollment in its ongoing Phase 3 clinical trial investigating emixustat hydrochloride (emixustat) in patients with macular atrophy secondary to Stargardt disease.

Key Points: 
  • Kubota Vision Inc. (Kubota Vision), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today that the company has completed subject enrollment in its ongoing Phase 3 clinical trial investigating emixustat hydrochloride (emixustat) in patients with macular atrophy secondary to Stargardt disease.
  • The study is a multi-center, randomized, double-masked, and placebo-controlled phase 3 clinical study in which subjects are randomly assigned to emixustat 10 mg or placebo (2:1 ratio) once daily for 24 months.
  • Dr. Kubota continued, We believe that this clinical trial adds value by accelerating rare disease therapy development.
  • Kubota Vision, the Kubota Vision logo and Kubota are registered trademarks or trademarks of Kubota Vision Inc. or Kubota Pharmaceutical Holdings in various jurisdictions.

Acucela Provides Update on Emixustat Phase 3 Clinical Trial in Patients with Stargardt Disease

Retrieved on: 
Thursday, February 13, 2020

Acucela Inc. (Acucela), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today that the company has achieved over 65% subject enrollment in its ongoing phase 3 clinical trial investigating emixustat hydrochloride (emixustat) in patients with macular atrophy secondary to Stargardt disease.

Key Points: 
  • Acucela Inc. (Acucela), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today that the company has achieved over 65% subject enrollment in its ongoing phase 3 clinical trial investigating emixustat hydrochloride (emixustat) in patients with macular atrophy secondary to Stargardt disease.
  • The FDA (U.S. Food and Drug Administration) and European Medicines Agency (EMA) granted orphan drug designation to emixustat for the treatment of Stargardt disease.
  • Stargardt disease affects less than 150,000 patients in total in the U.S., Europe and Japan where it is recognized as an orphan disease.
  • Acucela is exploring emixustats potential to stop or slow the progression of vision loss in patients diagnosed with Stargardt disease in an ongoing clinical study.

Acucela Announces Publication Assessing the Role of Emixustat Hydrochloride in Retinal Degeneration Treatment

Retrieved on: 
Monday, January 6, 2020

Authors of the paper explored the cellular and metabolic stressors associated with degenerative retinal diseases and the potential role of visual cycle modulation with emixustat in the treatment of these diseases.

Key Points: 
  • Authors of the paper explored the cellular and metabolic stressors associated with degenerative retinal diseases and the potential role of visual cycle modulation with emixustat in the treatment of these diseases.
  • The accumulation of toxic visual cycle byproducts and retinal hypoxia are stressors associated with retinal diseases such Stargardt disease (STGD) and diabetic retinopathy (DR), respectively.
  • Emixustats mechanisms of action and preclinical data supporting the role of emixustat in the treatment of these diseases is detailed.
  • This publication supports the rationale for investigating emixustat in the treatment of Stargardt disease and diabetic retinopathy.

Acucela Announces Publication of Pre-clinical Data for Emixustat Hydrochloride

Retrieved on: 
Monday, December 23, 2019

Acucela Inc. (Acucela), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), today announced the publication of pre-clinical data related to the companys investigational drug candidate, emixustat hydrochloride (emixustat), in the scientific journal Investigative Ophthalmology & Visual Science (IOVS).

Key Points: 
  • Acucela Inc. (Acucela), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), today announced the publication of pre-clinical data related to the companys investigational drug candidate, emixustat hydrochloride (emixustat), in the scientific journal Investigative Ophthalmology & Visual Science (IOVS).
  • The published article, Emixustat reduces metabolic demand of dark activity in the retina, can be accessed at: https://iovs.arvojournals.org/article.aspx?articleid=2756154 .
  • Authors of the paper evaluated the effects of emixustat on retinal metabolism in rat models.
  • Emixustat modulates the visual cycle by inhibiting a critical enzyme of this pathway, retinal pigment epithelium protein 65 (RPE65).