Ocugen Completes Dosing in Phase 1/2 GARDIAN Trial for OCU410ST Gene Therapy

Ocugen Completes Dosing in Phase 1/2 GARDIAN Trial for OCU410ST Gene Therapy

By, Admin 17 May 2024

Ocugen Completes Dosing of Stargardt Disease Patients in Phase 1/2 GARDIAN Trial for OCU410ST Gene Therapy

Overview

Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on developing novel gene and cell therapies as well as vaccines, has announced the completion of dosing in the second cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV-hRORA). This treatment is intended as a one-time therapy for Stargardt disease, aimed at modifying the gene associated with the condition.

Words from CMO: Ocugen

  • Dr. Huma Qamar, Ocugen’s Chief Medical Officer, highlighted the importance of reaching this milestone in the trial. 
  • She expressed optimism regarding the positive safety and tolerability profile demonstrated by OCU410ST, indicating the potential for higher doses as the study progresses. 
  • The company plans to share initial safety and efficacy data from Phase 1 soon.

Stargardt Disease & OCU410ST

  • Stargardt disease, which lacks FDA-approved treatments, presents a significant medical challenge. 
  • Dr. Benjamin Bakall, Director of Clinical Research at Associated Retina Consultants, emphasized the potential of OCU410ST to provide hope for patients with this condition. 
  • The completion of dosing for Cohort 2 represents a crucial advancement.

Safety Data Review Meeting

  • The trial’s Data and Safety Monitoring Board will meet next month to review safety data before advancing to Cohort 3, which involves administering the highest dose. 
  • The GARDian trial evaluates the safety and efficacy of OCU410ST in subjects with Stargardt disease, conducted in two phases.

Stargardt Disease

  • Stargardt disease affects approximately 100,000 individuals in the United States and Europe, leading to progressive vision loss due to retinal degeneration. 
  • OCU410ST employs an AAV delivery platform to deliver the RORA gene, targeting pathways associated with Stargardt disease.
  • Ocugen
  • Ocugen is dedicated to addressing the unmet needs of individuals with inherited retinal diseases. 
  • An update on the OCU410ST clinical trial is anticipated in the third quarter of 2024.

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