Edge Therapeutics Announces Additional Pharmacokinetic Data Supporting The Potential Clinical And Health Economic Impact Of EG-1962 In Aneurysmal Subarachnoid Hemorrhage
BERKELEY HEIGHTS, N.J., Sept. 06, 2016 (GLOBE NEWSWIRE) -- Edge Therapeutics, Inc. (Nasdaq:EDGE) today announced additional positive pharmacokinetic data from the Phase 1/2 NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study of its lead product candidate EG-1962 for the treatment of patients who have suffered an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm. Daniel Hänggi, M.D., Chairman, Department of Neurosurgery, University Medical Center Mannheim, Ruprecht-Karls-University, Heidelberg, Germany and lead NEWTON investigator presented the data today in an oral presentation at the European Association of Neurosurgical Societies’ 16th European Congress of Neurosurgery (EANS 2016) in Athens, Greece.
The pharmacokinetics of a single intraventricular dose of EG-1962 compared to the current standard of care, oral nimodipine, were studied in NEWTON. EG-1962 demonstrated stable plasma nimodipine concentrations following single administration that did not exceed plasma concentrations of oral nimodipine 60 mg given every four hours at a steady state. Cerebrospinal fluid (CSF) nimodipine concentration with EG-1962 was 100 to 1,000 times higher compared to plasma concentration and to CSF concentrations with oral nimodipine. These pharmacokinetics data support the favorable clinical outcome results and the observed median reduction in length of stay in the intensive care unit of 3.5 days and in the hospital of 2.5 days in EG-1962 treated patients in the NEWTON study.
“EG-1962 achieved the desired pharmacokinetic profile, with a steady-state sustained-release of nimodipine in plasma that increased with dose, and a desired high concentration in the cerebrospinal fluid versus the standard of care,” said Dr. Hänggi. “These data, together with previously reported positive safety, clinical outcome and health economic data, have established a strong basis for the recently initiated pivotal Phase 3 NEWTON 2 study.”
“These pharmacokinetic results, combined with our previously reported positive data that demonstrated EG-1962 more than doubled the chances of favorable clinical outcomes and shortened both ICU and hospital lengths of stay in the NEWTON study versus the standard of care after aSAH, reinforce our belief that EG-1962 may provide important benefits for patients,” said Brian A. Leuthner, Edge’s President and Chief Executive Officer. “We are committed to rapidly advancing the availability of EG-1962 for patients who suffer this life-threatening and catastrophic event in a field without improved treatment options in almost 30 years.”
Edge’s EANS 2016 presentation can be accessed in the Events & Presentations section of its website at: http://investors.edgetherapeutics.com/phoenix.zhtml?c=253911&p=irol-calendar.
About the NEWTON Study
NEWTON was a multicenter, randomized, controlled, open-label Phase 1/2 study evaluating the safety, tolerability and pharmacokinetics of escalating doses of EG-1962 compared to the current standard of care, oral nimodipine, in subjects with an aSAH. Pooled 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 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.
The NEWTON data supported the initiation of NEWTON 2, a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study comparing EG-1962 to oral nimodipine in adults with aSAH. For information on NEWTON 2, please visit the clinicaltrials.gov website and enter the identifier NCT02790632.
About EG-1962
EG-1962 is a novel polymeric nimodipine microparticle suspended in a diluent of hyaluronic acid that utilizes Edge Therapeutics’ proprietary PrecisaTM development platform designed to improve patient outcomes following an aSAH. EG-1962 has been granted orphan drug designation and Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with subarachnoid hemorrhage, and orphan drug designation by the European Commission (EC) for the treatment of patients with aSAH.
About aSAH
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 conditions. EG-1962, Edge’s lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aSAH, which is bleeding around the brain due to a ruptured brain aneurysm. For additional information about Edge, please visit www.edgetherapeutics.com.
Forward-Looking Statements
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 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.
Investor Contact: Gregory Gin Edge Therapeutics, Inc. Tel: 1-800-208-EDGE (3343) Email: ir@edgetherapeutics.com Media Contact: Laura Bagby 6 Degrees Tel: 312-448-8098 Email: lbagby@6degreespr.com