Egret Therapeutics Receives FDA Clearance of IND Application for EGT 101 for Treatment of Delayed Cerebral Ischemia
Egret Therapeutics, a clinical-stage biotechnology company focused on developing transformative therapies for neurological conditions, has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EGT 101 that is being studied for the treatment of Delayed Cerebral Ischemia (DCI) following aneurysmal subarachnoid hemorrhage. The Phase I/II trial is expected to begin enrolling patients in 2023.
“We are thrilled to have received IND clearance for our program in aneurysmal subarachnoid hemorrhage,” said Daniel Chai, M.D., Co-Founder and Chief Executive Officer of Egret Therapeutics, speaking on the FDA clearance.
“Clearance of this IND is a testament to the hard work and deep commitment from the Egret team in bringing drugs to the market that will help patients,” said Henry Park, Chief Financial Officer of Egret Therapeutics.
Among subarachnoid hemorrhage (SAH) patients who survive the initial bleed of a ruptured aneurysm, delayed cerebral ischemia (DCI) is the most important preventable cause of mortality and poor neurological outcome. “DCI prevention has been the focus of SAH research for decades, but few clinical options exist today. We are excited to move forward in our clinical development of EGT 101 with the hopes of bringing a therapy to patients where there is a high unmet need,” said Chris Jackson, M.D., Co-Founder and Chief Medical Officer of Egret Therapeutics.
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