Company Overview of Edge Therapeutics, Inc.
Edge Therapeutics, Inc., a hospital-focused biopharmaceutical company, designs and develops implantable technology for direct delivery of therapeutic compounds to the site of brain injury. Its drugs cover therapeutic areas, such as spontaneous brain hemorrhage, traumatic brain injuries, and brain surgeries. The company develops NimoGel and NimoVent to prevent delayed cerebral ischemia, a catastrophic delayed complication after subarachnoid hemorrhage. Its therapeutics are delivered to patients in the United States and internationally. The company was founded in 2009 and is based in New Providence, New Jersey.
139 South Street
New Providence, NJ 07974
Founded in 2009
Key Executives for Edge Therapeutics, Inc.
Co-Founder, Chief Executive Officer, President and Director
Co-Founder, Executive Vice President of Corporate Development and Director
Co-Founder, Chief Scientific Officer and Director
Chief Accounting and Operations Officer
Compensation as of Fiscal Year 2014.
Edge Therapeutics, Inc. Key Developments
Edge Therapeutics Reports Initial Data from its Phase 1/2 NEWTON Trial for EG-1962
Feb 11 15
Edge Therapeutics reported the progress of its ongoing Phase 1/2 NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study. NEWTON is a multicenter, randomized, controlled, open label clinical study of the company’s lead product candidate, EG-1962, which is designed to treat patients that have suffered a subarachnoid hemorrhage from a ruptured brain aneurysm. Edge has now completed enrollment of four cohorts of 12 patients (N = 48) in the NEWTON study, in which 36 were randomized to receive EG-1962 at 100 mg, 200 mg, 400 mg, and 600 mg and 12 were randomized to receive oral nimodipine, the current standard of care. Edge has also initiated enrollment of a fifth cohort of EG-1962 at an 800 mg dose. 90-day efficacy data is available for 24 patients from the first two- NEWTON patient cohorts. The 90-day favorable outcome rate for patients treated with EG-1962 was 61% (N = 11) versus 17% (N = 1) for oral nimodipine. Safety data is available for the first three cohorts (N = 36) and showed no evidence of hypotension in patients treated with EG-1962 while 33% (N = 3) of patients treated with oral nimodipine experienced hypotension. Edge has collected safety and 90-day functional outcome efficacy data for 24 aneurysmal subarachnoid hemorrhage (aSAH) patients enrolled in the first two cohorts of NEWTON with 18 patients receiving 100 mg (cohort 1) or 200 mg (cohort 2) of EG-1962 and six patients receiving oral nimodipine. Of the 18 patients who received EG-1962, 61% (N = 11) experienced a favorable outcome on the extended Glasgow Outcome Scale (eGOS). The eGOS is a validated 8 point scale (1 = death, 8 = good recovery) used to assess recovery for patients who have suffered a ruptured aneurysm. A favorable outcome in the NEWTON study protocol is defined as an eGOS score between 6 and 8 as measured 90 days after treatment. By contrast, only 17% (N = 1) of the six patients treated with oral nimodipine in the first two cohorts of the NEWTON study had a favorable outcome on the eGOS. Safety data from the third cohort (400 mg) who have not yet reached the 90-day functional outcome assessment are also available. Importantly, hypotension has not been observed among any patients who received EG-1962 in the first three cohorts (N = 27). By contrast, 33% (N = 3) of the 9 patients treated with oral nimodipine in the control group so far experienced hypotension. Safety and efficacy data for the fourth cohort are not yet available.
Edge Therapeutics, Inc. Appoints Renu Vaish as Vice President of Global Regulatory Affairs
Jan 8 15
Edge Therapeutics, Inc. announced that Renu Vaish, M.S. has been appointed Vice President of Global Regulatory Affairs, effective January 5, 2015. Ms. Vaish will direct the company’s worldwide regulatory strategy and initiatives and will report directly to Edge’s Chief Executive Officer, Brian Leuthner. Most recently she was Executive Director, Global Regulatory
Affairs at Celgene Pharmaceuticals, Inc.
Edge Therapeutics Announces Multi-Year Research and Discovery Collaboration with St. Michael's Hospital
Nov 18 14
Edge Therapeutics announced a multi-year research and discovery collaboration with St. Michael's Hospital. The collaboration will focus on new therapeutic approaches for the treatment of various acute neurological conditions resulting from neurovascular instability. This discovery collaboration brings together Edge's scientific expertise in neurovascular disease with the research and high-throughput drug screening resources of St. Michael's Hospital. Initially the collaboration will focus on using validated models of intracerebral hemorrhage, cavernous malformations, and traumatic brain injury developed by St. Michael's to rapidly screen libraries of compounds for therapeutic activity, and to identify and optimize lead candidates for Edge's early stage pipeline. As previously announced, Edge Therapeutics has initiated patient enrollment in the third cohort of its NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study, a multicenter, randomized, controlled, open-label, Phase 1/2 clinical trial of its lead product candidate EG-1962. The NEWTON study is evaluating the safety, tolerability and pharmacokinetics of EG-1962 compared to the current standard of care, oral nimodipine, in patients with aneurysmal subarachnoid hemorrhage (aSAH). Edge is also investigating a second compound, EG-1964, for prevention of recurrence of chronic subdural hematoma. The company plans to submit an IND for that treatment in 2015.
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