BERKELEY HEIGHTS, N.J., Dec. 09, 2016 (GLOBE NEWSWIRE) — Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage biotechnology company developing novel hospital-based therapies in the management of acute, life-threatening conditions, today announced that the results from its completed North American Phase 1/2 clinical study of EG-1962 are now available online through Stroke, a leading peer-reviewed journal from the American Heart Association, and are scheduled for print publication in the January 2017 issue of Stroke.
The publication, titled “Randomized, Open-Label, Phase 1/2a Study of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage,” describes the previously reported results of the North American Phase 1/2 NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study of EG-1962, Edge’s lead product candidate, in which all primary and secondary endpoints were achieved.
The NEWTON study, a multicenter, randomized, controlled, open-label Phase 1/2 study, evaluated the safety, tolerability and pharmacokinetics of escalating doses of EG-1962 compared to the current standard of care, oral nimodipine, in subjects with an aneurysmal subarachnoid hemorrhage (aSAH). Clinical outcome results of the North American NEWTON study showed that 60 percent of patients treated with EG-1962 achieved a favorable outcome (scores of 6-8 as measured by the Extended Glasgow Outcome Score [GOSE]) at 90 days, compared to 28 percent of patients in the active control standard of care, oral nimodipine, arm who achieved a favorable outcome. In addition, improved clinical outcome was supported by a reduction in vasospasm, delayed cerebral ischemia, reduced use of rescue therapies, and shorter intensive care unit (ICU) and overall hospital lengths of stay. Safety results showed that no patients experienced EG-1962 related hypotension, compared to 17 percent of patients treated with oral nimodipine.
Daniel Hänggi, M.D., Chairman, Department of Neurosurgery, University Medical Center Mannheim, Ruprecht-Karls-University, Heidelberg, Germany, lead NEWTON investigator and the lead author, said, “The North American NEWTON study results demonstrate EG-1962’s potential ability to fundamentally improve outcomes for patients suffering from an aSAH. In the study, intraventricular EG-1962 doubled the chances of favorable clinical outcome versus the standard of care, demonstrated a superior safety profile, and reduced ICU and hospital length of stay compared to oral nimodipine.”
“The publication in the Stroke journal shows why EG-1962 has the potential to become an important new therapy for aSAH patients and their loved ones,” said Brian A. Leuthner, Edge’s President and Chief Executive Officer. “The favorable NEWTON study results provide a strong rationale for conducting our pivotal Phase 3 NEWTON 2 study.”
Edge’s ongoing NEWTON 2 study is evaluating the safety and efficacy of EG-1962 compared to the standard of care oral nimodipine in approximately 374 adult patients who have suffered an aSAH.
EG-1962 is a novel polymeric nimodipine microparticle containing nimodipine suspended in a diluent of sodium hyaluronate. EG-1962 utilizes Edge’s proprietary PrecisaTM development platform and is designed to improve patient outcomes following aSAH. EG-1962 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA), and orphan drug designation by the FDA and the European Commission.
About the NEWTON 2 Study
The pivotal, Phase 3 NEWTON 2 study will assess the safety and efficacy of EG-1962 compared to standard of care oral nimodipine in approximately 374 adult patients who have suffered an aSAH. Patients in the experimental arm will receive a single 600 mg intraventricular injection of EG-1962 plus placebo capsules or tablets administered for up to 21 days. Patients in the active comparator arm will receive a single dose of intraventricular normal saline and up to 21 days of oral nimodipine capsules or tablets. The primary outcome measure will be the proportion of patients with a favorable outcome of six to eight as measured on the Extended Glasgow Outcome Scale (GOSE) at 90 days after the aSAH. Additional outcome measures are neurocognitive outcome at day 90 measured by the Montreal Cognitive Assessment (MoCA), safety (including delayed cerebral infarction at day 30) and health economic endpoints.
For additional information on NEWTON 2, please visit ClinicalTrials.gov and enter identifier: NCT02790632.
An aneurysmal subarachnoid hemorrhage is a brain hemorrhage after which blood from a ruptured aneurysm enters the subarachnoid space, the area between the middle and deepest protective layers of the brain. Approximately 600,000 individuals worldwide suffer an aSAH annually. In the U.S., approximately 35,000 aSAH patients, with an average age of 52, arrive alive at the hospital each year, and approximately 75 percent of these patients die or suffer permanent brain damage.
About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms for the management of acute, life-threatening neurological and other conditions. EG-1962, Edge’s lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, which is bleeding around the brain due to a ruptured brain aneurysm. Edge is evaluating EG-1962 in two clinical studies: the pivotal Phase 3 NEWTON 2 study of EG-1962 delivered via external ventricular drain, and a study of direct intracisternal administration of EG-1962. For additional information about Edge, please visit www.edgetherapeutics.com.
This press release and any statements of representatives of Edge Therapeutics, Inc. related thereto that are not historical in nature contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, without limitation, statements with respect to Edge’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,” “seeks,” “intends,” “plans,” “potential” or similar expressions, including statements with respect to Edge’s future clinical plans, Edge’s ability to advance its portfolio of therapies towards commercialization and the potential effects of its products. These statements are based upon the current beliefs and expectations of Edge’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 risk factors (many of which are beyond Edge’s control) as described under the heading “Risk Factors” in Edge’s filings with the United States Securities and Exchange Commission.
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