BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Edge Therapeutics today announced that the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation to EG-1962, the Company's lead product candidate, 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.
“We are very pleased to have received orphan drug designation for EG-1962. We believe our product can fundamentally improve patient outcomes following subarachnoid hemorrhage, which is such a catastrophic life-threatening condition.” said Brian Leuthner, President and Chief Executive Officer of Edge Therapeutics. “The benefits and incentives for an approved drug that has orphan drug designation, including marketing exclusivity periods, are strategically important from a regulatory and commercial perspective.”
In the U.S., approximately 35,000 people with an average age of 52 are hospitalized each year for aSAH, and approximately 75% of these patients die or suffer permanent brain damage within 30 days.
About Edge Therapeutics, Inc.
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 neurological conditions. EG-1962, our lead product candidate, has the potential to 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. EG-1964, our second product candidate, is being evaluated as a potential prophylactic treatment in the management of chronic subdural hematoma, to prevent recurrent bleeding on the surface of the brain.
About EG-1962 and EG-1964
EG-1962 is a novel polymeric nimodipine microparticle that utilizes Edge’s proprietary Precisa™ development platform. EG-1962 is designed to avoid the dose-limiting side effects associated with oral nimodipine, including hypotension, by administering treatment directly to the site of the injury. Edge is also formulating a second compound, EG-1964, for prevention of recurrence of chronic subdural hematoma.
About The NEWTON Study
The NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study is a multicenter, randomized, controlled, open-label clinical trial evaluating the safety, tolerability and pharmacokinetics of escalating doses of EG-1962 compared to the current standard of care, oral nimodipine, in subjects with aSAH.
As previously announced, Edge completed patient enrollment in all six cohorts of its ongoing Phase 1/2 NEWTON trial in North America. Safety data from the first three cohorts were also reported and no patients experienced EG-1962 related hypotension in the treated group, while 33% of patients treated with oral nimodipine experienced hypotension. The Company is also assessing patient functional outcomes at 90 days in each study cohort, which it believes could be indicative of the potential efficacy of EG-1962. At the mid-point of the study, favorable outcomes were reported in 67% of patients treated with EG-1962 compared with 22% of those patients treated with standard of care oral nimodipine.
EG-1962 and EG-1964 both utilize Edge’s proprietary, programmable, biodegradable polymer-based development platform, known as Precisa™. The Precisa platform allows Edge to create therapeutics capable of delivering medicines directly to the site of injury, providing a novel delivery mechanism that enables targeted and sustained drug exposure while potentially avoiding the systemic, dose-limiting side effects often associated with current standards of care.
For additional information about Edge Therapeutics, please visit www.edgetherapeutics.com.
This press release and any statements of representatives and partners of Edge Therapeutics, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” as defined in the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control).