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

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!