Healthcare Industry News:  NEWTON 2 

Biopharmaceuticals Neurosurgery

 News Release - July 29, 2016

Edge Therapeutics Announces First Patient Treated in Phase 3 NEWTON 2 Study of EG-1962 in Adult Patients with Aneurysmal Subarachnoid Hemorrhage

Pivotal, double-blind, placebo-controlled global study will compare EG-1962 to standard of care oral nimodipine

BERKELEY HEIGHTS, N.J., July 29, 2016 -- (Healthcare Sales & Marketing Network) -- Edge Therapeutics, Inc. (EDGE), a clinical-stage biotechnology company developing novel hospital-based therapies in the management of acute, life-threatening conditions, today announced that the first patient has been treated in NEWTON 2 (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage), a Phase 3, multi-center, multi-national, randomized, double-blind, placebo-controlled, parallel-group study comparing the efficacy and safety of EG-1962 to standard of care oral nimodipine in adults with an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm.

“The treatment of our first patient in NEWTON 2 is a significant milestone for Edge,” said Brian Leuthner, Co-Founder, President and Chief Executive Officer of Edge Therapeutics. “Our strong financial position and significant regulatory support, including EG-1962’s FDA Fast Track designation, potentially enables us to rapidly advance EG-1962 toward approval, so patients who’ve suffered this catastrophic event have the best chance at returning to a normal life.”

A ruptured brain aneurysm, caused by the weakening and subsequent rupturing of a blood vessel in the brain, is a life-threatening condition that affects more than 600,000 patients worldwide annually. In the U.S., more than 35,000 patients with ruptured brain aneurysms arrive alive at the hospital each year and, with current medical treatment, more than 75 percent die or suffer permanent brain damage within 30 days. The average age of a patient with a ruptured brain aneurysm in the U.S. is 52 years old.

“Delayed cerebral ischemia and the subsequent neurological deterioration is a devastating complication of subarachnoid hemorrhage,” said Sepideh Amin-Hanjani, M.D., study investigator and Professor of Neurosurgery, Co-Director of Neurovascular Surgery, Department of Neurosurgery at the University of Illinois Hospital and Health Sciences System, where the first patient has been enrolled. “We hope NEWTON 2 will duplicate the promising results of the Phase 1/2 NEWTON study so we may be able to provide a more effective, safe and convenient treatment option for patients than oral nimodipine.”

NEWTON 2 brings us closer to fulfilling our mission of transforming the treatment paradigm for patients suffering from ruptured brain aneurysms,” said R. Loch Macdonald, M.D., Ph.D., Co-Founder and Chief Scientific Officer of Edge Therapeutics. “We look forward to working with the study sites and investigators to advance this meaningful treatment that has the potential to improve the lives of critically ill aSAH patients and have a positive impact on their loved ones."

About the NEWTON 2 Study

The pivotal, Phase 3 NEWTON 2 study will assess the safety and efficacy of EG-1962 (nimodipine microparticles) compared to standard of care oral nimodipine in approximately 374 adult patients. Patients in the experimental arm will receive a single 600 mg intraventricular injection of EG-1962 plus placebo capsules or tablets administered for up to 21 days. Patients in the active comparator arm will receive a single dose of intraventricular normal saline and up to 21 days of oral nimodipine capsules or tablets. The primary outcome measure will be the proportion of patients with a favorable outcome of six to eight as measured on the Extended Glasgow Outcome Scale (GOSE) over 90 days. Additional outcome measures are neurocognitive outcome at Day 90 measured by the Montreal Cognitive Assessment (MoCA), safety (including delayed cerebral infarction at day 30) and health economic endpoints.

About the NEWTON Study

In August 2015, Edge announced data from the Phase 1/2 NEWTON trial of EG-1962, which established a maximum tolerated dose of 800 mg and showed a 59 percent favorable outcome as compared to a 28 percent favorable outcome for patients treated with oral nimodipine. In addition, improved efficacy was supported by a reduction in vasospasm, delayed cerebral ischemia, reduced use of rescue therapies, and shorter intensive care and overall hospital lengths of stay. Safety results showed that no patients experienced EG-1962-related hypotension, compared to 17 percent of patients treated with oral nimodipine.

Source: Edge Therapeutics

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