Edge Therapeutics Initiates Enrollment of Second Cohort in Phase 1/2 NEWTON Study of EG-1962 for Improvement of Outcome After Ruptured Brain Aneurysm
June 5, 2014
Data Safety Monitoring Committee recommends increased dose in second cohort and protocol amendment toallow dose-escalation to proceed between cohorts without interruption
BERKELEY HEIGHTS, N.J. – June 5, 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 second 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.
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 aneurysmal subarachnoid hemorrhage (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. EG-1962 is a novel polymeric nimodipine microparticle utilizing Edge’s proprietary PrecisaTM development platform and is being developed to improve patient outcome after aSAH, also commonly referred to as ruptured brain aneurysm.
“We are pleased to have initiated enrollment of the second cohort in NEWTON trial. With each patient cohort, we are collecting a substantial body of safety and efficacy data that we believe will validate our prior experience with EG-1962,” said Brian Leuthner, President and Chief Executive Officer of Edge Therapeutics. “The Data Safety Monitoring Committee recommendation reflects their confidence in EG-1962 based on the trial results thus far, and allows us to proceed efficiently with the study of EG-1962 as a potential replacement of standard of care treatment for ruptured brain aneurysm patients who receive an intraventricular catheter. We look forward to continued progress of the NEWTON study and to documenting its impact in this important patient population.”
Today’s announcement follows the protocol-specified review by the NEWTON study Data Safety Monitoring Committee (DSMC) of the safety and pharmacokinetic data from the first cohort of the trial, as well as of other exploratory clinical outcomes and non-clinical data. Based upon their review, the DSMC unanimously recommended increasing the dose of EG-1962 to 200 mg for the second cohort, as there were no unexpected drug-related serious adverse events, including hypotension, observed with the 100-mg dose of EG-1962 in the first cohort.
In addition to initiating enrollment of Cohort 2, the DSMC unanimously approved amending the protocol to allow dose-escalation to proceed without interrupting enrollment between cohorts in the absence of significant safety concerns related to EG-1962. The decision is expected to save at least 30 days of enrollment time for each cohort while assuring patient safety as the trial progresses.
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.pdsbiotech.com.
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.
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Edge Therapeutics, Inc.
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