BERKELEY HEIGHTS, N.J.–(BUSINESS WIRE)—November 4, 2014- Edge Therapeutics, a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies for acute, life-threatening neurological conditions, today announced that it has initiated patient enrollment in the third cohort of the NEWTON study, a multicenter, randomized, controlled, open-label, Phase 1/2 clinical trial of the company’s lead product candidate, EG-1962.
EG-1962 is a novel polymeric nimodipine microparticle that utilizes Edge’s proprietary PrecisaTM development platform and has the potential to improve patient outcome following aneurysmal subarachnoid hemorrhage (aSAH). It is designed to avoid the dose-limiting side effects associated with standard of care oral nimodipine, including hypotension, by administering treatment directly to the site of the injury.
Today’s announcement follows the protocol-specified review by the NEWTON Data Safety Monitoring Committee (DSMC) of the safety and pharmacokinetic data from the first two cohorts (n=24) of the trial, as well as of other exploratory clinical outcomes. Based upon its review, the DSMC unanimously recommended increasing the dose of EG-1962 to 400 mg for the third cohort of the trial, as there were no unexpected drug-related serious adverse events, including hypotension, observed with either the 200 mg dose of EG-1962 in the second cohort or the 100 mg dosage in the first cohort. In contrast, 3 of 6 (50%) patients randomized to standard of care oral nimodipine experienced hypotension.
“We are pleased to see that EG-1962 continues to exhibit the favorable safety profile we expected in this vulnerable patient population, and we are confident the efficacy data that we are collecting will both validate our early experience with EG-1962 and clearly define our regulatory path for approval in aSAH,” said Brian Leuthner, President and Chief Executive Officer of Edge Therapeutics. “We look forward to providing top-line results from the NEWTON study during the first half of 2015.”
The NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study is evaluating the safety, tolerability and pharmacokinetics of EG-1962 compared to the current standard of care, oral nimodipine, in patients with aSAH. The Company is also assessing patient functional outcomes at 30 and 90 days, which it believes will be indicative of the potential efficacy of EG-1962.
About Edge Therapeutics, Inc.
Edge Therapeutics is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening neurological conditions. EG-1962, our lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, or aSAH, which is bleeding around the brain due to a ruptured brain aneurysm. EG-1962 is a novel polymeric nimodipine microparticle that is administered directly into the brain ventricles. A single dose of EG-1962, administered initially at the time of aneurysm repair delivers a high concentration of nimodipine directly to the brain, with sustained drug exposure over 21 days. EG-1962 utilizes Edge’s proprietary, programmable, biodegradable polymer-based development platform, known as Precisa™. The Precisa™ platform allows Edge to create therapeutics capable of delivering medicines directly to the site of injury, providing a novel delivery mechanism that enables targeted and sustained drug exposure while potentially avoiding the systemic, dose-limiting side effects often associated with current standards of care. EG-1962 is currently being evaluated in the Phase 1/2 NEWTON study, a safety, pharmacokinetic and dose-escalation clinical trial. Our second product candidate, EG-1964, is being evaluated as a potential prophylactic treatment in the management of chronic subdural hematoma (cSDH), to prevent recurrent bleeding on the surface of the brain.
For more information on Edge Therapeutics, Inc., please visit: www.edgetherapeutics.com.
This press release and any statements of representatives and partners of 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), including, but not limited to, the timing and results of the Company’s clinical trials and the potential efficacy of EG-1962. 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.
Edge Therapeutics, Inc.
Gene Mack, Senior Director, Investor Relations, 800-208-EDGE
Jarrod Aldom, 973-442-1555 ext. 112