Ocugen to Discontinue Phase 3 oGVHD Trial
Ocugen 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, according to Ocugen. The company will analyze the full data when it is available.
“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,” Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen, said in a company news release. “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.