Eiger Announces Multiple Advances in Exendin 9-39 Program for the Treatment of Post-Bariatric Hypoglycemia (PBH)
"We have previously demonstrated positive proof of concept results in two separate single-day dosing studies at
The MAD study is a dose-ranging trial designed to examine efficacy, safety, and PK of multiple-ascending doses of SC exendin 9-39 after up to 3 days to prevent hypoglycemia and reduce hypoglycemic symptoms. Patients suffering from PBH are administered a baseline OGTT followed by administration of SC exendin 9-39 in a range of doses (0.05 to 0.4 mg/kg) for up to 3 days. Interim results for eleven patients who have completed up to 3 days of dosing were reported. All doses of exendin 9-39 led to an increase in glucose nadir (reduced magnitude of hypoglycemia) during OGTT on the last day of treatment. Patients administered SC exendin 9-39 doses ≥ 0.2 mg/kg demonstrated a mean 51% decrease in peak postprandial insulin levels, experienced desired therapeutic increases in glucose nadir, did not require rescue with IV dextrose, and experienced reduced neuroglycopenic (caused by a shortage of glucose in the brain) symptom scores. All doses administered were well-tolerated with headache or nausea as the only reported adverse events.
Eiger also reported the development of a proprietary, novel liquid formulation of exendin 9-39 which in dog studies has demonstrated a greater than two-fold increase in peak plasma concentrations compared to the original lyophilized powder of exendin 9-39. Development of a liquid formulation of exendin 9-39 represents an opportunity for lower dosing and once on the market, would eliminate the need for patients to dissolve powder in saline, a more convenient product presentation for patients. Eiger plans to evaluate the new exendin 9-39 liquid formulation in patients in the ongoing MAD study and also in a Phase 1 PK study scheduled for Q1 2017, both of which will inform the next, larger Phase 2 study planned for 2017.
In addition, Eiger announced today that exendin 9-39 has received Orphan Drug Designation from the
These results and updates were presented and webcasted during a Key Opinion Leader event hosted by Eiger on
About Insulin, GLP-1, and Exendin 9-39
Insulin is the principal physiologic hormone secreted to control high blood glucose levels. Abnormal increases in insulin secretion can lead to profound hypoglycemia (low blood sugar), a state that can result in significant morbidities, including seizures, brain damage, and coma. GLP-1 is a gastrointestinal hormone that is released postprandially from the intestinal L-cells. GLP-1 binds to GLP-1 receptors on the beta cells of the pancreas and increases the release of insulin. In patients with PBH, GLP-1-mediated insulin secretion is dysfunctionally exaggerated.
Exendin 9-39 is a 31-amino acid peptide that selectively targets and blocks GLP-1 receptors, normalizing insulin secretion by the pancreas, and thereby reducing postprandial hypoglycemia. Exendin 9-39 is being investigated as a novel treatment for PBH. Exendin 9-39 has been granted EU orphan designation by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS) and US orphan designation by the
About Post-Bariatric Hypoglycemia (PBH)
Approximately 150,000-200,000 bariatric surgical procedures are performed each year in
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse 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 identified, and for which an effective therapy is urgently needed. For more information, please visit the Company's website at 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, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39, including SC formulation, may be further developed and approved, whether Phase 2 studies of exendin 9-39 will show safety and activity consistent with early clinical results, including the interim results of the MAD study, or that the SC formulation will be consistent with results seen with IV exendin 9-39, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. 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 Annual Report on Form 10-K for the period ended
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