Edge Therapeutics Announces Updated Results from Phase 3 NEWTON 2 Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage
Clinically meaningful benefit observed in NEWTON 2 primary endpoint in pre-specified WFNS 3 or 4 (severe) subgroup
BERKELEY HEIGHTS, N.J., June 27, 2018 (GLOBE NEWSWIRE) -- Edge Therapeutics, Inc. (Nasdaq:EDGE) today announced updated results from its ongoing analyses of the Phase 3 NEWTON 2 study of EG-1962 in adults with aneurysmal subarachnoid hemorrhage (aSAH). As previously announced, upon the recommendation of a Data Monitoring Committee (DMC), Edge discontinued the NEWTON 2 study following a pre-specified interim analysis, conducted after 210 patients completed the Day 90 follow-up evaluation, that indicated a low probability of achieving a statistically significant difference compared to standard of care oral nimodipine in the study’s primary endpoint, were the study to be fully enrolled.
The Phase 3 multi-center, randomized, double-blind, placebo-controlled, NEWTON 2 study compared the efficacy and safety of EG-1962 to oral nimodipine in adults with aSAH. The NEWTON 2 study was designed to detect a 15% absolute improvement in favorable outcomes at Day 90 for the EG-1962 treatment group with a target enrollment of 374 subjects. Prior to discontinuation of the study, 283 subjects were randomized and treated. The current analysis includes 266 subjects who completed the Day 90 follow-up evaluation. This analysis showed that in the study’s primary endpoint, 45% (58/129) of subjects treated with a single intraventricular injection of EG-1962 experienced a favorable outcome (a score of 6 to 8 on the extended Glasgow Outcome Scale, or GOSE) at Day 90, compared to 41% (56/137) of subjects treated with oral nimodipine (see Table 1). The GOSE is a clinically validated scale to assess recovery for patients who have suffered a brain injury.
In the NEWTON 2 study, subjects were stratified at randomization by baseline severity as measured by the World Federation of Neurological Surgeons (WFNS) grade. In the pre-specified subgroup of subjects with WFNS grade 3 or 4 (severe aSAH subjects) 43% (29/67) of subjects treated with EG-1962 experienced a favorable outcome as measured by GOSE, compared to 29% (20/70) of subjects treated with oral nimodipine. While these results did not achieve statistical significance (as the NEWTON 2 study was not powered to provide statistical significance for subgroups), they suggest a clinically meaningful potential benefit for EG-1962 in subjects with WFNS grade 3 or 4. Further, these results are consistent with results from Edge’s Phase 1/2 NEWTON study. In that study, EG-1962 demonstrated a similar efficacy trend in favorable outcome rate compared to oral nimodipine in severe aSAH subjects with WFNS grades 3 or 4, with 37% (10/27) of the subjects treated with EG-1962 experiencing a favorable outcome, compared to 23% (3/13) of the subjects treated with oral nimodipine.
In the WFNS grade 2 subgroup (moderate aSAH subjects), favorable outcome rates from the the NEWTON 2 study (see Table 1) were inconsistent with those observed in the Phase 1/2 NEWTON study in both the EG-1962 and oral nimodipine treatment groups. In addition, the favorable response rate in the control group in NEWTON 2 was higher than, and inconsistent with, that reported in the medical literature.
Table 1. NEWTON 2 Phase 3 Study: GOSE 6-8 Favorable Outcomes by WFNS Subgroup
|WFNS 3-4 Subgroup||n=67||n=70|
|WFNS 2 Subgroup||n=62||n=67|
Edge did not identify any safety concerns that would have halted the NEWTON 2 study or precluded further development.
Edge expects to report the final analysis of data from all 283 subjects in the NEWTON 2 study when the data are available later this year.
Edge continues to conduct a review of strategic alternatives focused on maximizing stockholder value. Edge has largely completed the process of streamlining its operations, including reducing its headcount from 37 to 13 employees by June 30, 2018.
Edge has retained Piper Jaffray & Co. to act as its financial advisor to assist with the strategic alternatives review process. Potential strategic alternatives that may be explored or evaluated as part of this review include, but are not limited to, an acquisition, merger, business combination or other strategic transaction involving Edge.
About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. is a clinical-stage biotechnology company that seeks to discover, develop and commercialize novel, hospital-based therapies capable of transforming treatment paradigms for the management of acute, life-threatening conditions. 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 the potential effects of its products and plans to assess and undertake next steps for Edge. 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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