Eiger Announces Breakthrough Therapy Designation Granted by FDA for Avexitide for Treatment of Post-Bariatric Hypoglycemia (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 hypoglycemia," said
Avexitide is a well-characterized, first-in-class, 31-amino acid GLP-1 antagonist that selectively targets and blocks GLP-1 receptors, normalizing insulin secretion by the pancreas, and thereby reducing postprandial hypoglycemia. Avexitide has been dosed in 54 patients across four Phase 2 studies in patients suffering from PBH. 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
About Post-Bariatric Hypoglycemia (PBH)
Approximately 150,000-200,000 bariatric surgical procedures are performed each year in
Eiger is a late-stage biopharmaceutical company focused on the development and commercialization of a pipeline of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs and for which no approved therapies exist.
The Company's lead program is in Phase 3, developing lonafarnib, a first-in-class prenylation inhibitor for the treatment of Hepatitis Delta Virus (HDV) infection. The company is also advancing peginterferon lambda, a first-in-class interferon, toward a Phase 3 study for the treatment of HDV. Eiger is preparing an NDA and MAA for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies with plans to file in 2019. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, business strategy and plans and objectives for future operations, are forward looking statements. These forward-looking statements include terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "contemplate," "intend," "target," "project," "should," "plan," "expect," "predict," "could," "potentially" or the negative of these terms. Forward looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned clinical development, including plans to complete enrollment of our D-LIVR study by the end of 2019, submit an NDA and MAA for Progeria and progeroid laminopathies in 2019, complete end of Phase 2 meetings for peginterferon lambda in HDV and avexitide in post bariatric hypoglycemia; whether our Phase 2 study results will support further development of avexitide; and the potential safety, efficacy, clinical and pharmaco-economic benefits of our product candidates as well as the commercial opportunities, including potential market sizes and segments. These statements concern product candidates that have not yet been approved for marketing by the
Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the quarter ended
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