A phase 3 trial of Edge Therapeutics’ treatment for aneurysmal subarachnoid hemorrhage has come to a halt after an interim analysis. The data committee found Edge’s nimodipine microparticles were unlikely to better standard of care, prompting the biotech to stop the trial and prepare to lay off staff.
The recommendation to halt the study was based on an analysis of the performance of the first 210 participants enrolled in the study 90 days after they received a 600 mg intraventricular injection of EG-1962 or a saline placebo. Participants in the EG-1962 arm then received 21 daily placebo doses, while subjects in the control arm took oral nimodipine capsules or tablets.
Edge hoped to link EG-1962 to grades between upper moderate disability and upper good recovery on the eight-tier Extended Glasgow Outcome Scale that assesses head injury patients. The biotech’s belief in the asset was based on evidence it gets nimodipine—the go-to drug in the indication—to the brain in high concentrations without triggering the side effects associated with existing therapies. But 90-day data from the first 56% of planned enrollees in the study suggests it is unlikely to work.
Berkeley Heights, New Jersey-based Edge responded by stopping the trial. The biotech now plans to go over the unblinded data to figure out why the trial, which successfully came through a futility analysis late last year, hit the skids. The previous futility analysis was based on 90-day data on 150 patients.
While that work is going on, Edge will cut costs and hunker down. Edge is yet to provide full details of its plans but layoffs look set to form part of the strategy. The goal is to preserve the $88 million Edge had in the bank at the end of the year while it figures out its next steps.
The nature of Edge’s pipeline means the blow could be terminal. EG-1962 is Edge’s only clinical-stage candidate. Edge has performed preclinical work on delivering EG-1962 via different routes. Beyond those projects, the most advanced activity is a chronic subdural hematoma candidate that is still some way off the start of IND-enabling studies.
Investors responded to the setback by wiping 86% off Edge’s stock in premarket trading.