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.

“Delayed cerebral ischemia and the subsequent neurological deterioration is a devastating complication of subarachnoid hemorrhage.”

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.