US-based, clinical-stage, biotechnology company Edge Therapeutics has treated its first patient in the Phase III Nimodipine microparticles to enhance recovery while reducing toxicity after the subarachnoid hemorrhage (NEWTON II) trial of EG-1962, to treat aneurysmal subarachnoid hemorrhage (aSAH).
EG-1962 is a polymeric, nimodipine microparticle, composed of nimodipine suspended in a diluent of sodium hyaluronate.
It uses the company's patented Precisa development platform and is indicated to treat designed aSAH.
The multi-centre, multi-national, randomised, double-blind, placebo-controlled, parallel-group Phase III NEWTON II trial has been designed to determine the safety and efficacy of EG-1962 when compared with the standard of care oral nimodipine to treat aSAH.
During the trial, patients will be administered with a single 600mg intraventricular injection of EG-1962 and placebo capsules or tablets for 21 days.
University of Illinois Hospital and Health Sciences System neurovascular surgery department of neurosurgery professor and study investigator Sepideh Amin-Hanjani said: “Delayed cerebral ischemia and the subsequent neurological deterioration is a devastating complication of subarachnoid hemorrhage.
“We hope NEWTON II will duplicate the promising results of the Phase I/II NEWTON study so we may be able to provide a more effective, safe and convenient treatment option for patients than oral nimodipine.”
aSAH is characterised by a burst brain aneurysm caused due to the weakening and gradual rupture of a blood vessel of the brain.
Phase I/II NEWTON trials have demonstrated a positive outcome of EG-1962 administered in a maximum tolerated dosage of 800mg.
Patients exhibited improvements with a reduction in vasospasm, delayed cerebral ischemia and minimal rescue therapies, resulting in a reduced hospital stay.