Eiger Reports Additional Positive Phase 2 Results from Multiple-Ascending Dose Study of Exendin 9-39 in Post-Bariatric Hypoglycemia Patients at American Diabetes Association Meeting in San Diego
Results available from 19 of 20 patients were presented at the 2017
Key Findings:
SC exendin 9-39 liquid and lyophilized formulations:
- Reduced postprandial hyperinsulinemic hypoglycemia
- Reduced hypoglycemic symptoms
- Well tolerated with no related adverse events
SC exendin 9-39 liquid formulation:
- Improved postprandial metabolic and clinical parameters with comparable or greater activity versus the lyophilized formulation
- Produced a pharmacokinetic profile which may confer a longer duration of action versus the lyophilized formulation
"We are very encouraged by these results and our progress with SC exendin 9-39 in PBH patients, including data using Eiger's new proprietary liquid formulation of SC exendin 9-39," said
About the MAD Study
The MAD study, conducted at
Metabolic and clinical responses to oral glucose tolerance testing (OGTT) provocation on the final day of dosing were compared to baseline (pretreatment) OGTT responses, with symptoms of hypoglycemia assessed by use of the Edinburgh Hypoglycemia Symptom Scale (EHSS). The pharmacokinetic profile was evaluated after the first and last dose administered.
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 orphan designation in 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, lonafarnib, ubenimex or exendin 9-39, including SC formulations, may be further developed and approved, whether additional 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 new liquid formulation will be consistent with results seen with IV and SC formulations of 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 Quarterly Report on Form 10-Q for the three months ended
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