Eiger BioPharmaceuticals Completes Enrollment of Avexitide Study

Eiger BioPharmaceuticals announced completion of enrollment of the Phase 2 PREVENT study. PREVENT is a multi-center, placebo-controlled study investigating the safety and durability of effect of subcutaneous (SC) avexitide (formerly exendin 9-39) in post-bariatric surgical patients who experience dangerously low, postprandial blood glucose levels (hypoglycemia) known as post-bariatric hypoglycemia (PBH). A total of 18 patients were enrolled across five study sites in the United States. There is currently no FDA approved pharmacologic therapy for PBH.

At Eiger's request, avexitide has recently been adopted by the United States Adopted Name (USAN) Council and will be the International Nonproprietary Name (INN), which is used to identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized. A nonproprietary name is also known as a generic name. Eiger plans to seek approval for a proprietary name or brand name during Phase 3 development.

Avexitide is a first in class, GLP-1 antagonist in development as a convenient, novel liquid formulation for SC administration for PBH. Eiger has previously announced positive results from 3 separate proof of concept clinical studies involving 36 PBH patients treated with avexitide. Pharmacologic blockade of GLP-1 with avexitide has been shown to prevent hypoglycemia in post-bariatric surgical patients.

"Our previous clinical studies dosed PBH patients with avexitide for up to 3 days and demonstrated positive early proof of concept in the prevention of post-bariatric hypoglycemia during an oral glucose tolerance test (OGTT)," said Lisa Porter, MD, Chief Medical Officer, Metabolic Diseases at Eiger. "PREVENT is our first out-patient study evaluating multiple doses and durability of effect of avexitide for a treatment period of 28-days in patients suffering from PBH. We look forward to reporting top line results of the PREVENT study later this year."

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