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Post-bariatric hypoglycaemia

FDA grants avexitide Therapy Designation for post-bariatric hypoglycaemia

Third Eiger pipeline programme granted breakthrough therapy designation

Eiger BioPharmaceuticals has announced that the FDA has granted Breakthrough Therapy Designation for avexitide for the treatment of post-bariatric hypoglycaemia (PBH). FDA Breakthrough Therapy Designation involves a fast track development and FDA review process with guidance designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.

PBH is a chronic condition occurring in post-bariatric surgical patients leading to dangerously low, postprandial blood glucose levels. Severe PBH episodes can result in altered mental status, loss of consciousness, seizures, and coma. Due to increasing morbid obesity, the number of bariatric surgeries are increasing, leading to an increased number of patients suffering from PBH. Avexitide is a targeted, first-in-class, GLP-1 antagonist in development for the treatment of PBH, a chronic, debilitating disorder for which there is no approved treatment.

Approximately 150,000-200,000 bariatric surgical procedures are performed each year in the US, and another 100,000 are performed each year in Europe. The estimated prevalence of PBH is approximately 30,000 in the US and approximately 25,000 in the EU. As the number of bariatric surgeries to treat obesity and related comorbidities has increased, so too has the number of individuals who experience PBH, with symptoms typically developing one or more years following surgery. PBH can occur with a range of severity in post-bariatric surgical patients. Severe hypoglycaemia can result in neuroglycopenic outcomes (altered mental status, loss of consciousness, seizures, coma). Recurrent episodes of severe hypoglycaemia can be debilitating with a significant negative impact on quality of life. There is no approved treatment for PBH.

“Our avexitide PBH clinical program has dosed 54 patients across four Phase 2 studies, involving both inpatient and outpatient treatment, with promising results for patients suffering from post-bariatric hypoglycaemia,” said David Cory, President and CEO of Eiger. “We look forward to continued collaboration with the FDA, now on three Breakthrough Therapy Designation programs including lonafarnib for hepatitis delta virus (HDV) infection, lonafarnib for Hutchinson-Gilford Progeria Syndrome (Progeria) and Progeroid Laminopathies, and avexitide for post-bariatric hypoglycaemia.”

Avexitide is a well-characterized, first-in-class, 31-amino acid GLP-1 antagonist that selectively targets and blocks GLP-1 receptors, normalising insulin secretion by the pancreas, and thereby reducing postprandial hypoglycaemia. Avexitide is well-tolerated with the most common treatment emergent adverse events including mild to moderate injection site bruising, nausea, and headache.

Avexitide has been granted Breakthrough Therapy Designation by the FDA, as well as Orphan Drug Designation in the US by the FDA for the treatment of hyperinsulinemic hypoglycaemia and Orphan Drug Designation by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycaemia syndrome (NIPHS). Both of these broad orphan designations include PBH. Avexitide has never been approved or commercialized for any indication.

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