Edge Therapeutics is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening conditions.
We believe EG-1962, our lead product candidate, can fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, or aSAH, which is bleeding around the brain due to a ruptured brain aneurysm. A single dose of EG-1962 delivers a high concentration of nimodipine, the current standard of care, directly to the brain with sustained drug exposure over 21 days.
In April 2015, we completed enrollment in a Phase 1/2 trial of EG-1962 in North America, which we refer to as our NEWTON trial, and met our primary and secondary endpoints of safety, tolerability, maximum tolerated dose (MTD) and pharmacokinetics. We intend to initiate our Phase 3 program in the first half of 2016.
Our second product candidate, EG-1964, is being developed as a potential prophylactic treatment in the management of chronic subdural hematoma, or cSDH, to prevent recurrent bleeding on the surface of the brain. Recurrent bleeding occurs in up to 30% of cSDH patients, requires repeat neurosurgical intervention and is associated with risks of serious complications, including death. There are currently no approved therapeutic treatments that reduce the risk of recurrent bleeding after cSDH. Following discussions with the FDA, we intend to submit an IND for EG-1964 in 2016.