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Ocugen plans Phase I/II trials for macular disease gene therapies

2023-08-22

临床2期疫苗基因疗法细胞疗法临床1期

Phalguni Deswal

@Phalguni_GD

Ocugen announced that the manufacturing facility for its regenerative cell therapy for cartilage, NeoCart, is expected for completion by the end of 2023. Image Credit: Sergey Nivens / Shutterstock.

Phase I/II trials for Ocugen’s gene therapies, OCU410 and OCU410ST, are planned for initiation by the end of 2023 in geographic atrophy and Stargardt disease.

Ocugenans follow the US Food and Drug Administration’s (FDA) approval of the Investigational New Drug (IND) application for the two gene therapies.

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Ocugen is also planning for a Phase III trial in retinitis pigmentosa for OCU400 in Q4 2023/Q1 2024. The Phase III trial initiation is contingent on the FDA’s approval of trial plans and Phase I/II data.

OCU410 is an adeno-associated virus containing a geBcmahat eCd19es hWaldenstrom MacroglobulinemiaRAR)-related orphan receptor alpha (RORα). It is planned to be investigated in geographic atrophy, which is the chronic degeneration of the macula during the late stages of age-related macular degeneration.

OCU410ST was granted the orphan drug designation by the FDA for the treatment of Stargardt disease. Also known as ABCA4 retinopathy, the illness is a rare genetic disorder caused by pathogenic variations in the ABCA4 gene leading to fatty build-up on the macula and loss of vision.

OCU400 is an adeno-associated virus serotype 5 capsBCMAontaining the gene for human nuclear hormone receptor NR2E3. It is being developed in partnership with China-based CanSinoBIO. It is currently being evaluated in an open-label Phase II trial (NCT05203939).

An open-label Phase I trial (NCT05802329) for OCU200 in patients with diabetic macular oedema was initiated in Q2 2023. One of the cohorts in the trial will evaluate the combination therapy of OCU200 and Novartis’ Lucentis (ranibizumab).

Ocugen announced that the manufacturing facility retinitis pigmentosa cellOCU400py for cartilage, NeoCart, is expected for completion by the end of 2023,FDAth a Phase III trial for the therapy planned for initiation in H2 2024.

OCU410-based company is looking for government funding for its inhaled mucosal vaccine platform, with the IND application for the treatment expected to be filled in 2024.geographic atrophy age-related macular degeneration

OCU410STof their second quarter financials, Ocugen reporFDA cash equivalents of $Stargardt disease2023. The companABCA4 retinopathy loss of $0.10 per common share in Q2 2023.ABCA4 loss of vision

OCU400 Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.NR2E3 CanSinoBIO

Editorial content is independently produced anOCU200ows the highest stdiabetic macular oedema integrity. Topic sponsors are not involved in the creation of editorial content.OCU200 Novartis Lucentis ranibizumab

OcugenhitepaperCell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead.By Cytiva Thematic

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