The Conversation (0)
Edge Therapeutics Provides Update following Interim Analysis of Phase 3 NEWTON 2 Study of EG-1962
Mar. 28, 2018 08:52AM PST
Pharmaceutical Investing
Edge Therapeutics (Nasdaq:EDGE) announced that a pre-specified interim analysis performed on data from the Day 90 visit of the first 210 subjects randomized and treated in the Phase 3 NEWTON 2 study of EG-1962 in adults with aneurysmal subarachnoid hemorrhage (aSAH) demonstrated a low probability of achieving a statistically-significant difference compared to the standard of …
Edge Therapeutics (Nasdaq:EDGE) announced that a pre-specified interim analysis performed on data from the Day 90 visit of the first 210 subjects randomized and treated in the Phase 3 NEWTON 2 study of EG-1962 in adults with aneurysmal subarachnoid hemorrhage (aSAH) demonstrated a low probability of achieving a statistically-significant difference compared to the standard of care in the study’s primary endpoint, if the study is fully enrolled.
As quoted in the press release:
“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 Brian A. Leuthner, Edge’s President and Chief Executive Officer.
“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. R. Loch Macdonald, Edge’s Chief Scientific Officer.
Click here to read the full press release.
