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|Edge Therapeutics Provides Update following Interim Analysis of Phase 3 NEWTON 2 Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage|
Study Unlikely To Achieve Primary Efficacy Endpoint; DMC Recommends Discontinuation of Study
No Unexpected Safety Findings
Edge To Reduce Costs and Evaluate Next Steps
Edge To Host Conference Call on
The independent Data Monitoring Committee (DMC) recommended that the study be stopped based on its conclusion that the study has a low probability of meeting its primary endpoint. Favorable outcome was defined as a score of 6 to 8 on the extended Glasgow Outcome Scale, or GOSE, at Day 90. The DMC also reported that there were no safety concerns attributed to EG-1962.
Based on the DMC recommendation, Edge has decided to discontinue the NEWTON 2 study and has taken steps to notify health authorities and clinical investigators participating in the study. Edge will perform analyses of the cumulative unblinded data from the NEWTON 2 study to better understand the basis for this outcome.
“We are very disappointed that the NEWTON 2 study did not demonstrate evidence of improved outcomes with EG-1962, given the positive findings demonstrated on this measure in our randomized, open-label Phase 1/2 NEWTON study of EG-1962 in a similar patient population,” said
“We are grateful for the support and commitment from the participating patients, their families, study investigators and their teams, and the aSAH community,” said Dr.
Edge will assess the next steps for the company, but anticipates in the near term reducing the scope of its operations, including the size of its workforce, in order to preserve its cash resources, which were
Conference Call Details
Edge will host a conference call and webcast today,
About the NEWTON 2 Study
The Phase 3 NEWTON 2 study compared the efficacy and safety of EG-1962 (nimodipine microparticles) to standard of care oral nimodipine in adult patients with aneurysmal subarachnoid hemorrhage (aSAH). Patients in the experimental arm received a single 600 mg intraventricular injection of EG-1962 plus placebo capsules or tablets administered for up to 21 days. Patients in the active comparator arm received a single dose of intraventricular normal saline and up to 21 days of oral nimodipine capsules or tablets. The primary outcome measure was the proportion of patients with a favorable outcome of 6 to 8 on the Extended Glasgow Outcome Scale (GOSE) at the Day 90 visit. Additional measures were neurocognitive outcome at Day 90 assessed by the Montreal Cognitive Assessment (MoCA), safety (including delayed cerebral infarction at day 30) and health economic endpoints.
EG-1962 is a novel polymeric microparticle containing nimodipine suspended in a diluent of sodium hyaluronate designed to be administered through an external ventricular drain (EVD). EG-1962 utilizes Edge’s proprietary Precisa™ development platform and was designed to improve patient outcomes following aSAH. EG-1962 has been granted Fast Track designation by the
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