Business
Ocugen to Discontinue Phase 3 oGVHD Trial
Breakthrough Modifier Gene Therapy platform continues to advance towards clinic MALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a
About this update from Ocugen, Inc.
[{"type":"text","content":"Breakthrough Modifier Gene Therapy platform continues to advance towards clinic\nMALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage company focused on discovering, developing and commercializing transformative therapies to treat the whole eye, today announced the decision to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. Host Disease (oGVHD). The decision to stop the trial is based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion. The study was not stopped based on safety concerns. We will analyze the full data when it is available.\n “This is disappointing news, especially for those who suffer from oGVHD. Our hope was to provide the first treatment for this complex, orphan disease. We are grateful to the patients, their families and the investigators who participated in our clinical trial,” said Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “We are committed to advancing our transformative therapies and will shift our resources to focus on our breakthrough modifier gene therapy platform and novel biologic programs for patients suffering from blindness diseases. We remain on track to enter the clinic by next year with our first gene therapy product candidate, OCU400, which targets inherited retinal diseases. Our additional pipeline products, OCU410 and OCU200, which are focused on major retinal diseases, are targeted to enter the clinic by 2022. As a result of discontinuing this study and proceeds from our ATM program we believe that we have sufficient cash to fund our current operations into the fourth quarter of 2020. About OCU400 Ocugen is developing a modifier gene therapy platform to generate therapies designed to fulfill unmet medical needs in the area of retinal diseases, including inherited retinal diseases (“IRDs”). This modifier gene therapy platform is based on nuclear hormone receptors (“NHRs”), which have the potential to restore homeostasis, the basic biological processes in the retina and potentially rescue photoreceptors from degeneration. This technology was licensed from the Harvard Medical School. Unlike single-gene replacement therapies, which only target one gene at a time, we believe OCU400,...