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July 31, 2016updated 09 Sep 2022 11:41am

Edge Therapeutics treats first patient in Phase III NEWTON II trial of EG-1962 to treat aSAH

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).

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).

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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.

“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.

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As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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