Ocugen Announces Completion of Dosing in OCU400 Phase 1/2 Cohort 2
Ocugen, Inc. (NASDAQ: OCGN) announced that the Independent Data and Safety Monitoring Board completed a review of the safety data for its OCU400 Phase 1/2 clinical trial and recommends proceeding to enroll subjects in Cohort 3. No safety concerns were noted in the ongoing trial, which focuses on treating inherited retinal degeneration. The company expects to complete Cohort 3 enrollment by Q4 2022. OCU400 aims to address unmet needs in patients with retinitis pigmentosa associated with NR2E3 and RHO mutations.
- Positive recommendation from the Independent Data and Safety Monitoring Board for OCU400 trial.
- No safety concerns reported in ongoing clinical trial.
- Enrollment for Cohort 3 expected to be completed as planned in Q4 2022.
- None.
• No safety concerns noted in ongoing clinical trial
• Study timeline remains on track
MALVERN, Pa., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Independent Data and Safety Monitoring Board (DSMB) for the OCU400 Phase 1/2 clinical trial completed a review of safety data for subjects enrolled in Cohort 2 and recommends proceeding to enroll subjects in Cohort 3. The Company expects to complete Cohort 3 enrollment in Q4 2022 as planned.
“I’m very pleased with the progress of the clinical trial,” said David Birch, PhD, Director, Retina Foundation of the Southwest, primary investigator of the study. “Currently, patients with inherited retinal degeneration have nothing to address their condition in the long-term. It is imperative to keep working toward a solution for these patients who currently have no hope.”
OCU400 clinical trial is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa Associated with NR2E3 (Nuclear Receptor Subfamily 2 Group E Member 3) and RHO (Rhodopsin) Mutations. OCU400 is part of Ocugen’s Modifier Gene Therapy Platform—targeting inherited retinal disease and dry age-related macular degeneration.
About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.
Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.
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Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com
FAQ
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