Edge Therapeutics Completes Enrollment in Phase 1/2 NEWTON Study of EG-1962 for Patients with Ruptured Brain Aneurysm
May 28, 2015
Favorable Outcomes Reported in 67% of EG-1962 Treated Patients at Study Mid-point
BERKELEY HEIGHTS, N.J. – May 28, 2015 – Edge Therapeutics today announced that it has completed patient enrollment in all six cohorts of its ongoing Phase 1/2 NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) trial in North America. NEWTON is a multicenter, randomized, controlled, open-label clinical study of the Company’s lead product candidate, EG-1962, which is designed to treat patients that have suffered an aneurysmal subarachnoid hemorrhage (aSAH) from a ruptured brain aneurysm. The NEWTON study is evaluating the safety, tolerability, maximum tolerated dose (MTD) 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 90 days in each study cohort, which it believes could be indicative of the potential efficacy of EG-1962.
- A total of 72 patients have now been enrolled in six dosing cohorts, including 54 who have been randomized to receive EG-1962 (at doses of 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, or 1200 mg) and 18 randomized to receive standard of care oral nimodipine. There were no safety signals that precluded dose escalation in the study.
- Pooled 90-day outcome available for the first three NEWTON cohorts showed 18 of 27 EG-1962-treated patients (67%) experienced a favorable outcome as measured by scores on the extended Glasgow Outcomes Scale (GOSE). By contrast, the 90-day favorable outcome rate for patients treated with standard of care oral nimodipine in the first three cohorts was 22% (2 of 9). The GOSE is a validated 8-point scale (1 = death, 8 = good recovery) used to assess recovery for patients who have suffered a ruptured aneurysm. A favorable outcome in the NEWTON study protocol is defined as a GOSE score between 6 and 8 as measured 90 days after aSAH.
- Safety data available for the first three cohorts showed no evidence of EG-1962-related hypotension in patients treated with EG-1962, while 33% of patients treated with standard of care oral nimodipine experienced hypotension. A short-duration allergic reaction in one patient in Cohort 3 was reported as a serious adverse event (SAE); otherwise, no EG-1962-related SAEs have been reported in the first three cohorts.
“We continue to be encouraged by the results observed with EG-1962 in the first three cohorts of the NEWTON study,” said R. Loch Macdonald, MD, PhD, Chief Scientific Officer of Edge Therapeutics. “We look forward to the results from NEWTON cohorts at higher doses of EG-1962 to better characterize the safety, pharmacokinetic and efficacy profile of EG-1962.”
In the U.S., approximately 35,000 subjects with an average age of 52 are hospitalized each year for aSAH, and approximately 75% of these patients die or suffer permanent brain damage within 30 days.
“With the support of many patients, families, researchers, and health care professionals, we have made tremendous progress with the completion of North American enrollment for all six cohorts of the NEWTON study, which aims to fill a significant therapeutic gap for patients suffering from ruptured brain aneurysms,” said Brian Leuthner, President and Chief Executive Officer of Edge Therapeutics. “We look forward to expanding the development of EG-1962 in a pivotal program, which we hope to begin in the first half of 2016.”
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-1964, our second product candidate, is being evaluated as a potential prophylactic treatment in the management of chronic subdural hematoma, to prevent recurrent bleeding on the surface of the brain.
About EG-1962 and EG-1964
EG-1962 is a novel polymeric nimodipine microparticle that utilizes Edge’s proprietary PrecisaTM development platform. EG-1962 is designed to avoid the dose-limiting side effects associated with oral nimodipine, including hypotension, by administering treatment directly to the site of the injury. Edge is also formulating a second compound, EG-1964, for prevention of recurrence of chronic subdural hematoma.
About The NEWTON Study
The NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study is a multicenter, randomized, controlled, open-label clinical trial evaluating the safety, tolerability and pharmacokinetics of escalating doses of EG-1962 compared to the current standard of care, oral nimodipine, in subjects with aSAH.
EG-1962 and EG-1964 both utilize 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.
For additional information about Edge Therapeutics, 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).
Edge Therapeutics, Inc.
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