Eiger BioPharmaceuticals Announces New Data Supporting Broader Potential of Avexitide in Patients with Post-Bariatric Hypoglycemia and Hyperinsulinemic Hypoglycemia After Gastrointestinal Surgeries
- Data presented in oral presentation at ENDO 2022 on
- Avexitide significantly reduced the number of hypoglycemia events and the amount of time spent in hypoglycemia
- Study included patients who had undergone gastric bypass, vertical sleeve, total gastrectomy, or Nissen fundoplication procedures
"Patients suffering from hypoglycemia after bariatric and other gastrointestinal surgeries often experience debilitating symptoms and worsening in quality of life. With no approved treatments, current approaches such as nutrition therapy or off-label use of pharmacotherapies have limited efficacy and are often poorly tolerated," said
"These data further support the potential for avexitide as a targeted treatment to prevent hypoglycemia associated with gastrointestinal surgery, with consistent improvements observed across all surgical subtypes studied," added
Phase 2b Trial Results
This Phase 2b, open-label, investigator-initiated, cross-over study (NCT04652479) assessed the safety and efficacy of avexitide in hyperinsulinemic hypoglycemia after bariatric or other gastrointestinal surgeries. Sixteen patients with a history of recurrent hypoglycemia refractory to medical nutrition therapy (MNT) and exhibiting at least two severe hypoglycemia events while adhering to MNT over a 14-day period were included. Metabolic and symptomatic parameters were assessed by self-monitoring of blood glucose (SMBG), electronic diary (eDiary) and blinded continuous glucose monitoring (CGM) during 14 days of MNT as compared to 14 days of MNT + avexitide administered by subcutaneous injection at a dose of 45 mg twice daily or 90 mg once daily for a total of 28-days of treatment.
The primary and secondary endpoints, which measured frequency of hypoglycemia and amount of time in hypoglycemia, were met with statistical significance. Compared with MNT alone, avexitide 45 mg twice daily and 90 mg once daily reduced the rate of Level 1 hypoglycemia (SMBG <70 mg/dL) by 54% (p=0.003) and 68% (p=0.0005), respectively; Level 2 hypoglycemia (SMBG <54 mg/dL) by 57% (p=0.003) and 53% (p=0.004), respectively; and Level 3 hypoglycemia (severe event characterized by altered mental and/or physical function requiring assistance, as captured by eDiary) by 68% (p=0.0003) and 66% (p=0.0003), respectively.
Objective assessment by blinded CGM, substantiated SMBG, and eDiary results, with both dosing regimens (45 mg BID and 90 mg QD) demonstrating significant reductions in hypoglycemia events (up to 65%) and time spent in hypoglycemia (up to 64%). A greater magnitude of effect was consistently observed with once daily (90 mg QD) than twice daily (45 mg BID) dosing, as measured by blinded CGM.
Avexitide was well-tolerated, with no serious adverse events or participant withdrawals. The most common adverse events were diarrhea, headache, and injection site reaction/bruising.
About Post-Bariatric Hypoglycemia and Hyperinsulinemic Hypoglycemia after Gastrointestinal Surgeries
Post-bariatric hypoglycemia (PBH) and other forms of hyperinsulinemic hypoglycemia (HH) after gastrointestinal surgeries are characterized by exaggerated secretion of glucagon-like peptide-1 (GLP-1) after meals, dysregulated secretion of insulin, and a rapid drop in blood sugar. Hypoglycemia typically occurs one to three hours after meals and is often accompanied by symptoms of brain glucose starvation (neuroglycopenia), such as blurred vision, confusion, speech difficulty, and incoordination.
Severe hypoglycemia events can result in serious outcomes such as loss of consciousness, falls, seizures, and motor vehicle accidents, putting patients at risk for death and disability. Recurrent hypoglycemia events can have serious implications on quality of life, including heightened fear of hypoglycemia and reduced functionality, such as ability to work, drive, and independently perform activities of daily living.
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 on pancreatic beta cells and preventing GLP-1r signaling, avexitide works upstream of beta cell insulin secretion to reduce dysregulated insulin secretion and the occurrence of hypoglycemia. By addressing underlying disease mechanisms, avexitide may offer a targeted approach to treating hypoglycemia in patients with hyperinsulinemic hypoglycemia, including HI and PBH.
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