Clinical Proof of Concept Data Already Generated in Patients
PALO ALTO, California, November 12, 2015 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. today announced that it has acquired an exclusive license to a targeted therapeutic for treating post-bariatric surgical hypoglycemia. Gastric bypass procedures are widely performed and are increasing for medically complicated obesity, including Type 2 diabetes. The technology was invented by Tracey McLaughlin, MD, Associate Professor of Medicine at Stanford University Medical Center in the Division of Endocrinology.
Logo - http://photos.prnewswire.com/prnh/20151108/285009LOGO [http://photos.prnewswire.com/prnh/20151108/285009LOGO]
As the use of bariatric surgical procedures increases worldwide, a new post-surgical complication, hyperinsulinemic hypoglycemia, is increasingly reported. This disorder leads to frequent symptomatic hypoglycemia, often resulting in glucose concentrations low enough to cause seizures, altered mental status, loss of consciousness, cognitive dysfunction, disability and death. Quality of life can be severely diminished, and many patients cannot care for themselves or others, work, drive, or be left alone. There is no approved treatment for this condition, and severe cases have been surgically managed with near-total to total pancreatectomy, which results in insulin-dependent diabetes and is associated with up to a 6% surgical mortality risk.
"Research suggests that elevated glucagon-like-peptide (GLP-1) may play an important role in hyperinsulinemic hypoglycemia in post-bariatric surgery patients. Surgically-altered nutrient transit causes enhanced secretion of GLP-1 leading to elevated insulin secretion. This effect may play a primary role in the early resolution of Type 2 diabetes after surgery," said Joanne Quan, MD, Chief Medical Officer at Eiger. "An exaggeration of this same effect in some patients results in severe debilitating hypoglycemia. Stanford Researchers have now demonstrated in multiple clinical studies in patients that pharmacologic blockade of the GLP-1 receptor with Exendin (9-39) prevents hypoglycemia and improves symptoms. Exendin (9-39) may represent the first targeted medical treatment for patients with post-bariatric surgical hypoglycemia."
"Bariatric surgery for morbid obesity and Type 2 diabetes is a mainstay of treatment and as such, we expect to see the reported numbers of patients suffering from post-surgical hypoglycemia to increase in the future," said David Cory, President and CEO at Eiger. "There is no approved therapy for this disorder. Exendin (9-39) is a well-characterized compound that can be conveniently delivered as a targeted therapy, and encouraging clinical results have already been demonstrated by Dr. McLaughlin's team at Stanford University using different formulations and routes of delivery in patients suffering with hyperinsulinemic hypoglycemia."
About Bariatric Surgery Induced Hyperinsulinemic Hypoglycemia
Approximately 150-200,000 bariatric surgical procedures are performed each year in the United States, and another 125,000 are performed each year in Europe. The estimated prevalence of bariatric surgery-induced hyperinsulinemic hypoglycemia is expected to be less than 200,000 in the US and less than 5 in 10,000 in the EU, and eligible for Orphan Designation in the US and Europe.
About Exendin (9-39)
Exendin (9-39) is a well-characterized, competitive antagonist of glucagon-like peptide-1 (GLP-1) at its receptor. Administration of Exendin (9-39) blocks the GLP-1 receptor and leads to reduced insulin secretion by the pancreas. Exendin (9-39) is a 31 amino acid fragment of exenatide, a commercially available GLP-1 agonist that increases insulin secretion by the pancreas. Exendin (9-39), as a new molecular entity, has never been approved or commercialized for any indication.
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of Orphan diseases. The company has built a diverse, late-stage portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
Investors: Jim Shaffer, Eiger Bio, Inc., +1-919-345-4256, firstname.lastname@example.org [mailto:email@example.com]
Eiger BioPharmaceuticals, Inc.
Web site: http://www.eigerbio.com/