Edge Therapeutics raises $72.5 million to develop nimodipine microparticle

Edge Therapeutics raised $72.5 million through Series C-1 and C-2 financings. The $56 million C-2 round was led by Venrock with participation of Sofinnova Ventures, Janus Capital Management, Franklin Advisors, New Leaf Venture Partners and BioMed Ventures.

The company was established in 2009. The former CEO of Celgene, Dr. Sol Barer, is the current Board Chairman. Dr. Robert Langer, the most prolific inventor in medicine, has served as chair of Scientific Advisory Committee.

Edge is developing novel formulations of existing drugs with its Precisa platform. The foundation of Precisa is a biodegradable polymer called PLGA which can break down into lactic acid, releasing drugs slowly. Lupron Depot, an approved prostate cancer drug, uses PLGA to control the release profile of leuprolide as well.

Edge’s lead product candidate, EG-1962, is a PLGA-based nimodipine microparticle to prevent secondary strokes after subarachnoid hemorrhage (SAH). Patent WO2014164904 has disclosed the compositions of EG-1962.

SHA is usually caused by a ruptured brain aneurysm. Brain aneurysm can be treated with surgery, but the delayed strokes are more difficult to control. Current treatment guidelines recommend SAH patients to receive nimodipine every four hours over a 21-day period.

Nimodipine is a dihydropyridine calcium channel blocker which inhibits contractions of vascular
smooth muscle. When given orally or intravenously, nimodipine causes low blood pressure in 5% of patients, which should be carefully monitored in the treatment.

EG-1962 can be placed in the brain after surgery, locally releasing nimodipine over the course of 21 days. The microparticles sustain a high concentration of nimodipine in the brain and avoid systemic side effects including hypotension at the same time.

EG-1962 is currently in a Phase I/II trial (NEWTON). In February 2015, Edge reported initial data from the trial. The 90-day favorable outcome rate for patients treated with EG-1962 was 61% (n=11/18) vs. 17% (n=1/6) for oral nimodipine.

Hypotension has not been observed among any patients who received EG-1962 in the first three cohorts (n=27). By contrast, 33% of the nine patients treated with oral nimodipine experienced hypotension.

These results are consistent with the original hypothesis. Edge plans to provide top-line results from the NEWTON in 2015H1 and to initiate Phase III trials in 2015H2.

Furthermore, Edge’s second product candidate, EG-1964 (aprotinin filament), will enter clinical trials in 2015 to prevent recurrent bleeding after subdural hematoma (SDH).

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