Eiger Announces Publication of Positive Phase 2 Results of Avexitide in Children with Congenital Hyperinsulinism and Launch of Phase 3 Program

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– Phase 2 study demonstrating that avexitide significantly reduces hypoglycaemia in children with congenital hyperinsulinism published in Diabetic treatments
– Eiger plans to launch avexitide Phase 3 registration program by year-end 2022

PALO ALTO, Calif., April 25, 2022 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR), a commercial-stage biopharmaceutical company focused on developing innovative therapies to treat and cure hepatitis delta virus (HDV) and other serious diseases, today announced the publication of data demonstrating that treatment with avexitide significantly reduced the likelihood of fasting and protein-induced hypoglycemia in patients with congenital hyperinsulinism (HI).

Eiger BioPharmaceuticals (PRNewsFoto/Eiger BioPharmaceuticals, Inc.)

The investigator-sponsored study conducted at the Children’s Hospital of philadelphia cream (CHOP) provides further evidence of avexitide’s targeted therapeutic approach to treat IH and supports the advancement of avexitide into Phase 3 development.

“CHOP has been a strong supporter and development partner of avexitide, and we are delighted to see the publication of these positive results,” said David Cory, President and CEO, Eiger. “Their first investigation of avexitide in congenital hyperinsulinism has generated important fundamental proof-of-concept data in this patient population. avexitide has the potential to transform the lives of children with this life-threatening condition.”

Eiger has obtained alignment with the FDA on the avexitide HI registration program. Avexitide has received Orphan Drug Designation in the United States from the FDA for the treatment of hyperinsulinemic hypoglycemia (which includes IH) and has also received Rare Pediatric Disease Designation, making it eligible for a priority review voucher after regulatory approval. Avexitide is the only investigational treatment for IH to have received Breakthrough Therapy designation from the FDA.

“The impact of this disease on patients and families can be devastating, with newborns often requiring hospitalization in intensive care, surgery and years of intensive care,” said the lead author. study, Diva D. De León-Crutchlow, MD, chief of the Division of Endocrinology and Diabetes and director of the Center for Congenital Hyperinsulinism at Children’s Hospital of philadelphia cream. “With no approved treatments for IH currently available, new effective therapies are urgently needed. Eiger’s initiation of the avexitide Phase 3 program is therefore an important milestone for this community.”

Summary of Phase 2 Study Results1

This open-label, crossover study (N=16) was designed to test the effects of avexitide (referred to as exendin (9-39) in the study) versus salt control on fasting-induced hypoglycemia and protein in children with SALU. Compared to the control group, avexitide treatment resulted in a 76% reduction in the likelihood of fasting hypoglycaemia in the mid-dose group (0.44 mg/kg) and an 84% reduction in the likelihood hypoglycemia in the high dose group (0.6 mg/kg). group. Treatment with avexitide (0.6 mg/kg) during protein tolerance testing resulted in an 82% reduction in the risk of hypoglycaemia. The mid-dose group also demonstrated a 20% increase in fasting blood sugar, while the high dose resulted in a 28% increase in blood sugar after a meal and a 30% increase in blood sugar after protein challenge.

About Congenital Hyperinsulinism (HI)

Congenital hyperinsulinism (HI), a rare genetic disorder, is the most common cause of persistent hypoglycemia (low blood sugar) in infants and children. The estimated incidence between 1 in 2,500 and 1 in 50,000 live births2-3 results in approximately 80-100 new cases of IH in the United States each year, 60% of which are diagnosed within the first month of life. It is characterized by inappropriate and persistent insulin secretion from pancreatic beta cells and results in permanent brain damage with neurodevelopmental deficits in up to 50% of patients. Near-total pancreatectomy is often indicated and leads to lifelong insulin-dependent diabetes (IDDM). There are no approved therapies for IH; safe and effective therapies are urgently needed to prevent brain damage, IDDM and death.

About Avexitide

Avexitide is an investigational glucagon-like peptide-1 receptor (GLP-1r) antagonist in development for the treatment of congenital hyperinsulinism (HI) and post-bariatric hypoglycemia (PBH). Avexitide has received Breakthrough Treatment designation for IH and BPH.

By binding to GLP-1r, avexitide inhibits GLP-1r signaling, thereby reducing dysregulated insulin secretion and preventing fasting and protein-induced hypoglycemia. By addressing the underlying mechanisms of disease, avexitide may offer the first targeted approach to treating hypoglycemia in patients with IH. Eiger has developed a new formulation of avexitide for subcutaneous injection for its Phase 3 registration program.

About the Eiger

Eiger is a commercial-stage biopharmaceutical company focused on developing innovative therapies to treat and cure hepatitis delta virus (HDV) and other serious diseases. The Eiger HDV platform includes two first-in-class Phase 3 therapies that target critical host processes involved in viral replication. Eiger is also developing peginterferon lambda as a therapeutic agent for COVID-19 and plans to submit an emergency use authorization request to the FDA based on positive results from the TOGETHER-sponsored phase 3 study. investigator.

Eiger’s five rare disease programs have received FDA Breakthrough Therapy designation: lonafarnib and peginterferon lambda for HDV, Zokinvy for progeria, and avexitide for HI and BPH.

For more information about Eiger and its clinical programs, please visit www.eigerbio.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding our future financial condition, timing and clinical outcome results, regulatory objectives, business strategy, and plans and objectives for future operations, are forward-looking statements. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyzes or current expectations regarding, among other things, our anticipated milestones in 2022; the timing of our ongoing and planned clinical development; the adequacy of our cash, cash equivalents and investments to fund our operations; our ability to obtain emergency use authorization from the FDA for peginterferon lambda for COVID-19; our ability to supply sufficient quantities of any of our product candidates, including peginterferon lambda, to meet anticipated large-scale commercial demands; our ability to fund the continued advancement of our development pipeline products; and the potential for success of each of our product candidates. A variety of important factors could cause actual results or events to differ materially from Eiger’s forward-looking statements, including additional applicable risks and uncertainties described in the “Risk Factors” sections of the Annual Report on Form 10-K for the fiscal year ended in December. 31, 2021 and Eiger’s subsequent filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events, changed circumstances or otherwise.

CONTACTS:
Investors:
Sylvia Wheeler
Wheelhouse Life Science Advisors
[email protected]

Media:
Sarah Mathieson
SVP, Corporate Affairs
[email protected]

1. Stefanovski D, Vajravelu M, Givler S, De León D. Diabetic treatments, 2022; DOI: 10.2337/dc21-2009; 2. Bruining GJ. Curr Opin Pediatr, 1990; 2:758–765; 3. Otonkoski T et al. Diabetes, 1999; 48:408–415.

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SOURCEEiger BioPharmaceuticals, Inc.

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