PALO ALTO, Calif., Nov. 29, 2016 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of therapies for rare diseases, today announced an update on the Company's development program for exendin 9-39 as a potential treatment for post-bariatric hypoglycemia (PBH), a rare, debilitating and chronic disorder with no approved treatment. Eiger is developing a novel subcutaneously-administered form of exendin 9-39 for patients who experience dangerously low post-prandial (post-meal) blood glucose levels due to PBH.
Eiger has now filed an investigational new drug (IND) application for exendin 9-39 with the FDA. Eiger is the exclusive licensee of exendin 9-39 from Stanford University, which, under the Stanford IND, has generated and presented promising proof of concept data in multiple studies in patients with PBH, including an intravenous (IV) infusion study of exendin 9-39 and a subcutaneous injection (SC) study involving single-ascending doses (SAD) of exendin 9-39. Eiger is currently sponsoring a multiple-ascending dose (MAD) study involving SC exendin 9-39 in patients with PBH at Stanford, with interim data to be presented at a Company-hosted Analyst / Key Opinion Leader (KOL) event on December 9th. "We are pleased to achieve the milestone of filing of our own IND application for exendin 9-39, accelerating our pathway toward conducting a chronic dosing study to elucidate longer duration treatment of exendin 9-39 in patients with PBH, which should enable us to design a registration program," said David Cory, President and CEO of Eiger. "PBH represents a serious and large unmet medical need for patients who experience dangerous and debilitating effects of hypoglycemia due to this disorder, and for whom dietary modification alone is ineffective. There are currently no approved therapies for PBH, representing a therapeutically and commercially valuable market opportunity for SC exendin 9-39 that aligns well with our strategic focus on rare diseases." Analyst / KOL Event Planned for December 9, 2016 Eiger will host an Analyst / KOL event on December 9th at the Lotte New York Palace Hotel in New York City from 8:00 AM to 9:30 AM (EST). This webcasted event will feature keynote presentations by endocrinology specialists, Mary-Elizabeth Patti, MD, Marzieh Salehi, MD, and Colleen Craig, MD, who will discuss new approaches to treating PBH. In addition, an overview of Eiger's PBH program, including a discussion of interim data from the MAD study with exendin 9-39, will be presented. The Company anticipates that data from the completed MAD study will inform the Phase 2b trial, planned for initiation in 2017. To date, approximately 30 patients with PBH have been treated with exendin 9-39 at Stanford University. In an oral presentation at the June 2016 American Diabetes Association's 76 th Scientific Sessions, Stanford investigators presented positive data from an 8-patient SAD study aimed at evaluating the pharmacokinetics, pharmacodynamics and tolerability of SC exendin 9-39 in patients with PBH. These data complemented results from a previous trial involving IV infusion of exendin 9-39, and demonstrated that pharmacologic blockade of GLP-1 receptors with SC exendin 9-39 could also prevent post-prandial hypoglycemia and improve associated symptoms in patients with PBH during an oral glucose tolerance test. No adverse reactions to exendin 9-39 were reported in the SAD study. 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 post-prandially 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.