The US Food and Drug Administration (FDA) has accepted Edge Therapeutics' Investigational New Drug (IND) application for EG-1962, a novel bio-absorbable nimodipine microparticle formulation. Edge Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing life-saving hospital products for acute, fatal or debilitating conditions.

Edge is developing EG-1962 for the prevention of delayed cerebral ischemia (DCI), a life-threatening complication of subarachnoid haemorrhage (SAH). The application was accepted within 30 days of submission to the FDA.

The opening of this IND will allow the company to begin enrolling patients in a phase I/II clinical trial evaluating the safety and tolerability of EG-1962 for prevention of DCI. The multinational trial will include up to 96 patients in approximately 20 centres in North America and Europe. Edge expects to enroll the first patient for the trial in the third quarter of 2013.

“There are nearly 90,000 people each year in North America and Europe who are at risk to develop DCI, most of whom could be candidates for EG-1962,” said Brian Leuthner, president and CEO of Edge Therapeutics. “FDA acceptance of this IND application is a significant milestone for Edge Therapeutics and allows us to further advance EG-1962 and potentially help patients who are in a very vulnerable state.”

There have been no significant advancements for more than two decades in the treatment of DCI. Oral nimodipine is the current standard of care treatment for DCI, yet despite its universal use, one-third of patients continue to develop DCI and its devastating consequences. Edge’s objective is to develop a new therapeutic approach to address this important unmet medical need.

“We are in need of better therapies to prevent DCI and are extremely pleased to initiate this study to compare EG-1962 in a head-to-head trial against oral nimodipine,” said R Loch Macdonald, MD, PhD, chief scientific officer of Edge, Endowed Chair of Neurosurgery at St. Michael’s Hospital in Toronto, Canada and widely-known researcher in SAH.

Delayed cerebral ischemia (DCI) is a delayed life-threatening neurological condition that occurs as a result of subarachnoid haemorrhage (SAH), a neurovascular event that is most commonly caused by a ruptured brain aneurysm (aneurysmal SAH) or a traumatic brain injury (TBI). DCI is a major cause of death and disability in patients who are treated in the hospital for SAH. DCI commonly affects the working population (average age 50 years old) and occurs in approximately one-third of patients during the first two weeks after SAH, often resulting in substantial disability or death.