Phase 3 of the NEWTON 2 Study of EG-1962 in aSAH Is Unlikely to Meet Primary Endpoint

Today, Edge Therapeutics released an update on its interim analysis of Phase 3 of the NEWTON 2 study of EG-1962 in aneurysmal subarachnoid hemorrhage (aSAH), stating its current data indicates the study (if fully enrolled) has a low probability of achieving a statistically significant difference compared to the standard of care in the study’s primary endpoint. Based on the independent Data Monitoring Committee’s (DMC) recommendation the study be stopped, Edge Therapeutics decided to terminate the study.

aSAH is the rupture of a brain aneurysm, causing bleeding in the space between the brain and tissue covering the brain.

EG-1962 is a novel polymeric microparticle that contains nimodipine suspended in a diluent of sodium hyaluronate, which is designed to be administered through an external ventricular drain (EVD).¹ In relation to aSAH, it attempts to improve patients’ outcomes following aSAH. While EG-1962 has not shown efficacy in Phase 3 of its study, it was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and orphan drug designation by the FDA and European Commission.

Phase 3 of the NEWTON 2 study sought to compare the safety and efficacy of EG-1962 (nimodipine micoparticles) to the standard of care of oral nimodipine in adult patients with aSAH. In the experimental arm, participants were administered a 600 mg intraventricular injection of EG-1962 plus placebo capsules or tablets that were given for up to 21 days. In the active comparator, participants were administered a single dose of intraventricular normal saline and oral nimodipine capsules or tablets for up to 21 days.¹

The proportion of patients with a favorable outcome of 6 to 8 on the Extended Glasgow Outcome Scale (GOSE) at the day 90 visit was the primary outcome measure. Health economic endpoints, safety (including delayed cerebral infraction at day 30), and neurocognitives outcomes were secondary outcomes.

Data from the 210 subjects on the day 90 visit indicates the EG-1962 treatments in adults with aSAH had a low probability of achieving a greater standard of care than the current standard.

Brian A. Leuthner, Edge’s President and Chief Executive Office, expressed his disappointment with the drug’s inefficacy. “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.”

While the NEWTON 2 study has proven to be unsuccessful, Edge will analyze the unblinded data from the study for a better understanding of the outcome.

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Reference:

1. “Edge Therapeutics Provdes Update following Interim Analysis of Phase 3 NEEWTON 2 Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage.” GlobeNewswire. 28, Mar. 2018.