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September 01, 2015 8:21 AM ET

Pharmaceuticals

Company Overview of Edge Therapeutics, Inc.

Company Overview

Edge Therapeutics, Inc., a clinical-stage biotechnology company, discovers, develops, and commercializes hospital-based therapies for acute life-threatening neurological conditions. Its lead product candidate, EG-1962, a polymer-based microparticle used for the treatment of aneurysmal subarachnoid hemorrhage (cSDH). The company also develops other product candidates, which are in pre-clinical development stages, including EG-1964, to prevent recurrent bleeding after treatment for cSDH; and EG-1963, to prevent rebleeding following surgeries outside the brain. Edge Therapeutics, Inc. was founded in 2009 and is headquartered in Berkeley Heights, New Jersey.

200 Connell Drive

Suite 1600

Berkeley Heights, NJ 07922

United States

Founded in 2009

18 Employees

Phone:

800-208-3343

Fax:

908-790-1212

Key Executives for Edge Therapeutics, Inc.

Co-Founder, Chief Executive Officer, President, and Director
Co-Founder, Chief Scientific Officer, and Director
Co-Founder, Executive Vice President of Corporate Development and Director
Chief Financial Officer
Age: 55
Chief Accounting and Operations Officer
Compensation as of Fiscal Year 2015.

Edge Therapeutics, Inc. Key Developments

Edge Therapeutics Receives FDA Orphan Drug Designation for EG-1962 for the Treatment of Patients with Subarachnoid Hemorrhage

Edge Therapeutics announced that the U.S. Food and Drug Administration has granted orphan drug designation to EG-1962, which is in clinical trials treating patients that have suffered an aneurysmal subarachnoid hemorrhage (aSAH), also known as a ruptured brain aneurysm. Orphan drug designation is granted for novel drugs or biologics to treat rare medical diseases or conditions that affect less than 200,000 people in the United States. The designation qualifies the sponsor for numerous incentives including seven years of market exclusivity after the drug's approval, tax credits for clinical research costs and application fee reductions.

Edge Therapeutics Reports Initial Data from its Phase 1/2 NEWTON Trial for EG-1962

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

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.

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