Eiger Announces Publication of Positive Phase 2 Results of Avexitide in Children with Congenital Hyperinsulinism and Initiation of Phase 3 Program
- Phase 2 study demonstrating avexitide significantly reduced hypoglycemia in children with congenital hyperinsulinism published in Diabetes Care
The investigator sponsored study conducted at
"CHOP has been a strong supporter and development partner for avexitide, and we are pleased to see the publication of these positive results," said
"The impact of this disease on patients and families can be devastating, with newborns often requiring intensive care hospitalization, surgery, and years of intensive management," said senior study author Diva
This open-label, crossover study (N=16) was designed to test the effects of avexitide (referred to as exendin (9-39) in the study) compared to a saline control on fasting- and protein-induced hypoglycemia in children with HI. Compared to control, avexitide treatment resulted in a 76% reduction in the likelihood of fasting hypoglycemia in the mid-dose (0.44 mg/kg) group and an 84% reduction in the likelihood of hypoglycemia in the high dose (0.6 mg/kg) group. Avexitide treatment (0.6 mg/kg) during protein tolerance testing resulted in an 82% reduction in the likelihood of hypoglycemia. The mid-dose group also demonstrated a 20% increase in fasting glucose, while the high dose resulted in a 28% increase in glucose after a meal and a 30% increase in glucose after protein challenge.
Congenital hyperinsulinism (HI), a rare genetic disease, is the most common cause of persistent hypoglycemia (low blood sugar) in infants and children. The estimated incidence of between 1 in 2,500 and 1 in 50,000 live births2-3 results in approximately 80-100 new cases of HI in the
Avexitide is an investigational, first-in-class glucagon-like peptide-1 receptor (GLP-1r) antagonist in development for the treatment of congenital hyperinsulinism (HI) and post-bariatric hypoglycemia (PBH). Avexitide has been granted breakthrough therapy designation for both HI and PBH.
By binding to the GLP-1r, avexitide inhibits GLP-1r signaling, thereby reducing dysregulated insulin secretion and preventing fasting- and protein-induced hypoglycemia. By addressing underlying disease mechanisms, avexitide may offer the first targeted approach to treatment of hypoglycemia in patients with HI.
Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure hepatitis delta virus (HDV) and other serious diseases. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.
All five Eiger rare disease programs have been granted FDA breakthrough therapy designation: lonafarnib and peginterferon lambda for HDV, Zokinvy for progeria, and avexitide for both HI and PBH.
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
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SVP, Corporate Affairs
1. Stefanovski D, Vajravelu M, Givler S, De León D. Diabetes Care, 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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