Biotech

Edge Therapeutics (Nasdaq:EDGE) 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 …

Edge Therapeutics (Nasdaq:EDGE) 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.

As quoted in the press release:

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.

Click here to read the full press release.

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