Edge Therapeutics, a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies for acute, life-threatening neurological conditions, today announced that it has initiated patient enrollment in the second cohort of the NEWTON study, a multicenter, randomized, controlled, open-label, Phase 1/2 clinical trial of the company's lead product candidate, EG-1962.
The NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study is evaluating the safety, tolerability and pharmacokinetics of EG-1962 compared to the current standard of care, oral nimodipine, in patients with aneurysmal subarachnoid hemorrhage (aSAH). The company is also assessing patient functional outcomes at 30 and 90 days, which it believes will be indicative of the potential efficacy of EG-1962. EG-1962 is a novel polymeric nimodipine microparticle utilizing Edge's proprietary PrecisaTM development platform and is being developed to improve patient outcome after aSAH, also commonly referred to as ruptured brain aneurysm.
"We are pleased to have initiated enrollment of the second cohort in NEWTON trial. With each patient cohort, we are collecting a substantial body of safety and efficacy data that we believe will validate our prior experience with EG-1962," said Brian Leuthner, President and Chief Executive Officer of Edge Therapeutics. "The Data Safety Monitoring Committee recommendation reflects their confidence in EG-1962 based on the trial results thus far, and allows us to proceed efficiently with the study of EG-1962 as a potential replacement of standard of care treatment for ruptured brain aneurysm patients who receive an intraventricular catheter. We look forward to continued progress of the NEWTON study and to documenting its impact in this important patient population."
Today's announcement follows the protocol-specified review by the NEWTON study Data Safety Monitoring Committee (DSMC) of the safety and pharmacokinetic data from the first cohort of the trial, as well as of other exploratory clinical outcomes and non-clinical data. Based upon their review, the DSMC unanimously recommended increasing the dose of EG-1962 to 200 mg for the second cohort, as there were no unexpected drug-related serious adverse events, including hypotension, observed with the 100-mg dose of EG-1962 in the first cohort.
In addition to initiating enrollment of Cohort 2, the DSMC unanimously approved amending the protocol to allow dose-escalation to proceed without interrupting enrollment between cohorts in the absence of significant safety concerns related to EG-1962. The decision is expected to save at least 30 days of enrollment time for each cohort while assuring patient safety as the trial progresses.
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