Edge Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing life-saving hospital products for acute, fatal or debilitating conditions, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company´s Investigational New Drug (IND) application for EG-1962, a novel bio-absorbable nimodipine microparticle formulation. Edge is developing EG-1962 for the prevention of delayed cerebral ischemia (DCI), a life-threatening complication of subarachnoid hemorrhage (SAH). The application was accepted within 30 days of submission to the FDA.
The opening of this 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 trial will include up to 96 patients in approximately 20centers 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.
About Delayed Cerebral Ischemia
Delayed cerebral ischemia (DCI) is a delayed life-threatening neurological condition that occurs as a result of subarachnoid hemorrhage (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.1,2,3 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. The Company´s patent-protected bio-absorbable microparticle formulations are intended to 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 intravenously-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 generic 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
This press release and any statements of representatives and partners of Edge Therapeutics, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” as defined in the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law
1 Frontera JA, Fernandez A, Schmidt JM, et al. Defining vasospasm after subarachnoid hemorrhage: what is the most clinically relevant definition? Stroke 2009;40:1963-8.
2 Kassell NF, Torner JC, Haley EC Jr, Jane JA, Adams HP, Kongable GL. The International Cooperative Study on the Timing of Aneurysm Surgery. Part 1: Overall management results. J Neurosurg 1990;73:18-36.
3 Vergouwen MD, de Haan RJ, Vermeulen M, Roos YB. Effect of statin treatment on vasospasm, delayed cerebral ischemia, and functional outcome in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis update. Stroke 2010;41:e47-e52.
