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Edge Therapeutics, Inc.
Biotech Specialty Pharma
211 Warren Street
Newark, NJ 07103 USA
phone:800-208-EDGE
fax:800-208-3343
Symbol Private
Founded 2009
Employees 5
www.edgetherapeutics.com
Research Sector Biotech Specialty Pharma
Summary Description
Edge seeks to revolutionize treatment to prevent secondary brain injury after hemorrhagic stroke and traumatic brain injury and challenge current oral and intravenous methods by delivering life-saving medicine directly to the brain.
Management
Brian A. Leuthner-President & CEO; R. Loch Macdonald, MD, PhD. - Chief Scientific Officer, Carl J. Soranno, Esq. - Executive Vice President, Business Development
Keywords
subarachnoid hemorrhage, SAH, ruptured aneurysm, SAH, vasospasm Brain research, Pharmaceutical studies, Strokes

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Updated: Apr. 25, 2012

Description
Edge Therapeutics seeks to revolutionize treatment to prevent secondary brain damage after hemorrhagic stroke or traumatic brain injury (TBI) by taking today's minimally effective off-patent drugs and delivering them directly to the brain via proprietary sustained-release formulations. Unlike the many past investment and treatment failures for the primary injury to the brain from stroke or TBI � which suffered from significant logistical barriers such as strict timing requirements regarding stroke onset or hospital admission � Edge�s clearly identified target patients are already hospitalized and under the care of a neurosurgeon or neurointensivist and can be treated before their secondary brain injury occurs.
Products / Services
NimoGel, Edge's lead product, is being developed to prevent secondary strokes after subarachnoid hemorrhage (SAH), which is caused by bleeding into the fluid around the brain. NimoGel combines a generic calcium channel blocker nimodipine, formulated in a biodegradable polymer carrier composed of FDA-approved materials. Specifically, NimoGel is a combination of the widely used validated drug with a proven, proprietary, GRAS-designated, sustained-release formulation.
Technology / Differentiation
Today's treatment to prevent secondary brain injury after stroke and TBI are limited and only marginally effective because standard oral or intravenous administration fails to provide adequate doses of protective drug to the site of brain injury. Higher doses that might prevent secondary injury result in significant side effects such as lowering of blood pressure, heart attacks, and ischemic strokes.
Market / Customers
The annual U.S. direct and indirect costs of SAH exceed $20B, and those of TBI total more than $60B. Worldwide, the WHO estimates that sudden brain injury costs hundreds of billions of dollars annually. Edge's value proposition is that by reducing 30-day mortality, reducing cerebral infarction, and reducing intensive care unit (ICU) length of stay, hospitals will increase ICU throughput and substantially decrease overall costs.
Competitors / Substitutes / Alternatives
Today's treatment to prevent secondary brain injury after stroke and TBI are limited and only marginally effective because standard oral or intravenous administration fails to provide adequate doses of protective drug to the site of brain injury. Higher doses that might prevent secondary injury result in significant side effects such as lowering of blood pressure, heart attacks, and ischemic strokes.
Strategy
Edge plans to advance its products to Proof of Concept in 4q2012 / 1Q 2013 and exit via sale of the company.
Funding
Edge has raised more than $1.2M through a small group of private investors and grants. Edge was awarded a $500,000 grant from the New Jersey Commission on Science and Technology Edison Innovation Fund. Edge also received $100,000 in funding from the New Jersey Economic Development Agency and is awaiting results of >$2M in FAST-TRACK grant opportunities from the National Institutes of Health as well as the Department of Defense.
Status
MILESTONES TO DATE: In the 15 months since it's founding, Edge Therapeutics has: 1. Submitted U.S. and Worldwide patent applications to protect key intellectual property 2. Secured sourcing for the active pharmaceutical ingredient (API) nimodipine with UQUIFA 3. Signed a formulation feasibility agreement with SurModics Inc. to develop NimoGel 4. Demonstrated that nimodipine can be efficiently encapsulated into NimoGel (Fig. 2) 5. Demonstrated that NimoGel can safely be sterilized by gamma radiation without degradation of the API 6. Identified multiple formulations that provide ideal burst rates for NimoGel 7. Demonstrated that NimoGel can deliver nimodipine over the selected 14-day time period 8. Demonstrated preliminary NimoGel efficacy in a large animal model.