Edge Therapeutics believes it can combat the delayed, life-threatening effects that can happen days or weeks after aneurysms and severe head injuries by tweaking well-known drugs. With its biggest financial haul to date, the New Providence, NJ-based biotech will get its first chance to test that thesis on a large scale by putting its lead drug, EG-1962, in a mid-stage clinical trial. Edge said today that it has raised $18 million in a Series C round, bringing its total equity funding since its inception in 2009 to about $24 million, plus an additional $1.5 million in state and federal grants, according to president and CEO Brian Leuthner. Edge wouldn’t reveal its investors—Leuthner called them “primarily high net worth folks”—but it has clearly attracted some big names: Former Celgene CEO Sol Barer joined on as Edge’s chairman in October, and MIT bioengineering professor Bob Langer heads its scientific advisory committee.
Edge was co-founded by Leuthner, who held senior positions at acute-care focused pharmaceutical companies such as Medicines Co. and ESP Pharma (acquired for $500 million by Protein Design Labs in 2005), and R. Loch Macdonald, the head of St. Michael’s Hospital’s neurosurgery division, in 2009. The idea behind the company is to change the formulations and delivery mechanisms behind already-approved drugs to ultimately prevent the potential deaths or devastating effects that can occur as a result of delayed reactions to cerebral hemorrhages, or severe head injuries.
That may seem like a small change, but Leuthner looks at it as one with big potential. Edge’s lead drug, he says, can be potential blockbuster—meaning more than $1 billion in sales annually if it can clear the clinical and regulatory hurdles necessary to get to market—because of the limitations of current treatments.
After a doctor plugs up an aneurysm, a patient is at risk typically from three to 14 days for cerebral vasospasm, a narrowing of the arteries in the brain that can ultimately choke off the blood and oxygen supply to the brain—a condition known as delayed cerebral ischemia. Typically, doctors try to prevent instances of cerebral vasospasm by giving patients an oral form of nimodipine, a drug approved by the FDA more than 20 years ago. Edge contends that because of the way that nimodipine is delivered into the body, it isn’t nearly as effective as it could be: a majority of the patients can’t get the right, concentrated dose of it without dealing with other complications such as low blood pressure or blood pooling in the lungs.
“You’re limited by both the blood-brain barrier and the systemic side effects, so we’re overcoming both of that,” Leuthner says.
There are about 35,000 to 40,000 patients that arrive alive at the hospital with an aneurysm in the U.S. each year, and about 180,000 in the U.S. that are hospitalized for traumatic brain injury, according to Leuthner.
Edge plans to fix the problems of nimodipine by reformulating the drug into a single, sustained-release injection administered right at the end of the emergency procedure that a doctor performs to stop the bleeding in a patient’s brain. The injection is administered via a catheter that has already been placed in the brain to help drain excess fluid from the area. The effects of the injection are designed to be released over the course of 21 days, according to Leuthner.
Edge uses the technology of Germany’s Evonik Degussa Corp. to create the formulation.
Edge’s drugs are only in the early stages of development, so it has a long way to go, but by using different forms of already-approved drugs, its plan is to make its path through clinical trials and regulatory approval shorter—and thus cheaper.
“This is not your typical development plan where it’s going to take 10 or 12 years to get approval,” he says. “We think around five years or so is what it’s going to take to get these drugs approved.”
Edge has already completed its early-stage study of EG-1962 and will present the results at the International Conference on Neurovascular Events after Subarachnoid Hemorrhage in Switzerland in July (Leuthner declined to offer details of the study). The new $18 million will largely go towards kick-starting a mid-stage clinical trial for the drug, the plans for which Edge will announce later this year, according to Leuthner.
Edge has to prove, of course, that the idea works. But its business plan is to use this concept and apply it to other delayed complications from brain hemorrhages, traumatic brain injury, and brain surgery, such as chronic subdural hematoma (a recurring blood clot in the brain).
Edge aims to hold on to the North American rights to its drugs at the very least, and fully believes it can successfully set up shop on its own in the U.S. and sell its drugs to the “200 or so” hospitals that currently treat about 70 percent of the patients it is targeting, according to Leuthner.
“The plan is to make this a pharmaceutical company and build it,” Leuthner says. “All of us believe that given our pipeline that we actually are able with 25 sales reps to build a very profitable company here in the [United States].”