Phase III NEWTON 2 study of EG 1962 updates results in aneurysmal subarachnoid hemorrhage.- Edge Therapeutics.

Edge Therapeutics announced updated results from its ongoing analyses of the Phase III NEWTON 2 study of EG 1962 (nimodipine polymer based) 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.

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. 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 I/II 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. 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.