Edge a step closer to hemorrhage drug approval after FDA fast-track

Starting line

Returning from a quiet period after it got off its discounted IPO last fall, NJ-based Edge Therapeutics has today announced that the FDA has given the biotech a fast-track designation for its experimental aneurysmal subarachnoid hemorrhage treatment.

This will speed up the time it takes the FDA to review EG-1962, a polymeric nimodipine microparticle that delivers nimodipine--which is seeking to become the standard of care in patients with aneurysmal subarachnoid hemorrhage (aSAH).

Generic nimodipine is in fact the drug of choice in this setting--and was originally developed as blood pressure treatment--but Edge believes that by using its polymer technology it can deliver higher doses than is currently possible.

aSAH is a brain hemorrhage after which blood from a ruptured aneurysm enters the subarachnoid space, the area between the middle and deepest protective layers of the brain. Around 35,000 aSAH patients, with an average age of 52, arrive alive at the hospital each year, but around 75% of these patients die or suffer permanent brain damage, according to the biotech.

In a Phase II study, EG-1962 bested oral nimodipine in improving clinical outcomes for patients with aSAH.

The biotech said it is now actively planning for its Phase III Newton 2 pivotal/confirmatory study to evaluate the efficacy and safety of EG-1962 to nimodipine. Edge expects the study to open for enrollment in mid-2016.

The drug has already received an orphan drug designation by the FDA and by the European Commission.

“We are very pleased that FDA has granted Fast Track designation for EG-1962 for the treatment of SAH,” said Brian Leuthner, Edge’s CEO.

“The FDA Fast Track designation builds upon the orphan drug designations EG-1962 received from both the FDA and European Commission last year, and provides us with even more momentum to address the significant unmet medical needs in the treatment of aneurysmal subarachnoid hemorrhage (aSAH), also known as a ruptured brain aneurysm. We look forward to working closely with the regulatory authorities to rapidly advance the availability of EG-1962 for patients that suffer this life-threatening and catastrophic event.”

Edge raised had raised around $72.5 million in two funding rounds in 2014/15, with help from Sofinnova Venture Partners, Venrock and others. It decided to float in fall of last year and raise $115 million--although in September this had been be pulled back to around $85 million at $11 a share.

Beyond EG-1962, Edge is working on a treatment for chronic subdural hematoma, a build-up of blood between the brain and its outermost covering often caused by trauma.

That drug, EG-1964, contains the anti-bleeding agent aprotinin, an effective treatment whose use is hampered by serious side effects. Using the same polymer technology at work in EG-1962, the company has crafted a formulation it believes can make aprotinin safe at higher doses.

- check out the release