Vasospasm 2013 Conference Features Oral Presentation of Edge Therapeutics? EG-1962

Edge Therapeutics today announced that researchers from Heinrich Heine University in Düsseldorf, Germany presented positive results of the first clinical application of EG-1962 (nimodipine microparticles), a sustained release injectable formulation of nimodipine for improvement of outcome and prevention of delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH). The results were featured in an oral presentation at Vasospasm 2013, the 12th International Conference on Neurovascular Events after Subarachnoid Hemorrhage in Lucerne, Switzerland, a meeting that attracts hundreds of prominent neurovascular specialists from around the world.

SAH is a life-threatening form of hemorrhagic stroke that typically results from a ruptured brain aneurysm or traumatic brain injury and is often complicated by DCI, which has a high likelihood of causing death or disability. There are approximately 90,000 patients in North America and Europe who are at risk for DCI following aneurysmal SAH, most of whom would be candidates for EG-1962.

“Despite clinicians’ best efforts to prevent permanent disability or death during the course of aneurysmal SAH, the effective reduction of DCI and poor functional outcome remains challenging,” commented Daniel Hänggi, M.D., principal investigator of the study and Vice Chairman of the Department of Neurosurgery at Heinrich Heine University. “EG-1962 appears to be a promising new approach to preventing DCI, based on the results from this initial group of patients,” added Nima Etminan, M.D., co-principal investigator and staff neurosurgeon at Heinrich Heine University.

Dr. Etminan presented data from their open-label study in which 11 patients received one-time administration of EG-1962 in doses ranging from 40 mg to 400 mg. Ten of the patients met the study’s enrollment criteria, which included documented severe aneurysmal SAH and treatment within 48 hours of aneurysm rupture. No EG-1962-related adverse events, such as toxic drug effects or systemic hypotension, were reported for any patients. In patient No. 1, who received the 40-mg dose, levels of nimodipine in the plasma and cerebrospinal fluid (CSF) were suboptimal, whereas for patients treated with the 100-mg dose or higher, plasma and CSF levels of nimodipine were within the therapeutic range over the analyzed period. No patients meeting enrollment criteria who received the 100-mg dose or higher demonstrated any clinical or radiological features of DCI or cerebral infarction on computed tomography (CT) imaging. After 6 weeks post-SAH, all patients meeting enrollment criteria were rated a 5 (good recovery) on the 5-point Glasgow Outcome Scale (GOS), a measure of outcome after head injury and nontraumatic acute brain insults. One patient was treated after more than 48 hours of aneurysm rupture and was a protocol deviation. This patient died due to the natural course of aneurysmal SAH unrelated to EG-1962 administration.

“We are greatly encouraged by the apparent prevention of DCI and improvement in outcome, as well as by the lack of side effects in this initial study of EG-1962,” said Dr. Hänggi, “We hope to see these results replicated in additional studies.”

Last month Edge announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for EG-1962. The opening of the lND will allow the company to begin enrolling patients in a Phase 1/2 clinical trial evaluating the safety and tolerability of EG-1962 for prevention of DCI. The multinational Phase 1/2 trial, expected to commence in the third quarter of 2013, will include up to 96 patients in approximately 20 centers in North America and Europe. Dr. Hänggi, M.D. will serve as principal investigator for this study.

About Delayed Cerebral Ischemia

Delayed cerebral ischemia (DCI) is a delayed, life-threatening neurological condition that occurs as a result of SAH, which is most commonly caused by aneurysmal SAH or traumatic brain injury (TBI). DCI is a major cause of death and disability in patients who are treated in the hospital for SAH.^1,2,3 According to the World Health Organization and the International Brain Injury Association, at least two million people each year suffer conditions that put them at risk for DCI. 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.¹

About Edge Therapeutics, Inc.

Edge Therapeutics, Inc. is a private, clinical-stage biopharmaceutical company focused on developing and commercializing life-saving hospital products that improve patient outcome by addressing acute, fatal or debilitating conditions after brain hemorrhage that have no current effective treatment. Edge uses its novel site-specific and sustained-release microparticle technology platform to deliver drugs to the brain to prevent complications of subarachnoid hemorrhage, subdural hematoma and intracerebral hemorrhage, all of which currently have no effective therapies. The Company’s patent-protected bioabsorbable microparticle formulations release drugs locally and consistently at therapeutic concentrations in the brain, with the objective of maximizing therapeutic activity and avoiding treatment-limiting systemic side effects seen with current treatments. Currently, oral- or IV-administered therapies are employed in suboptimal concentrations due to the generation of systemic side effects. Edge’s lead product candidates, EG-1962 (nimodipine microparticles) and EG-1964, are being developed to prevent various delayed complications after brain hemorrhage. EG-1962 is a proprietary microparticle formulation of the calcium channel blocker nimodipine, while EG-1964 delivers a hemostatic agent. For more information on Edge Therapeutics, Inc., please visit: www.edgetherapeutics.com.

Forward Looking Statements

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