First Patient Treated in Phase 2 PREVENT Study of Exendin 9-39 for Post-Bariatric Hypoglycemia

First Patient Dosed in Phase 2 PREVENT Study of Exendin 9-39 for Post-Bariatric Hypoglycemia

On Monday, rare disease-focused biopharma company Eiger announced treatment of the first patient in the PREVENT study, a phase 2, multicenter study of subcutaneous (SC) exendin 9-39 in post-bariatric surgical patients who experience hypoglycemia (PBH).

The primary point of the PREVENT study (a Phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study) is to assess the efficacy and safety of exendin 9-39 in patients with PBH.

Researchers behind the PREVENT trial aim to enroll 20 PBH patients from across the US. Randomized participants will be assigned to one of two treatment arms in a 1:1 ratio. Each participant will receive 2 dosing regimens of exendin 9-39 and a matching placebo that will be self-administered via an SC injection. Participants will also undergo concomitant blood draws and symptom assessments in combination with in-clinic mixed meal tolerance tests (MMTTs).

Exendin 9-39 is a first-in-class GLP-1 antagonist in development as a convenient, novel liquid formulation for SC administration for PBH. Since 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, the European Medicines Agency (EMA) has granted the drug orphan designation for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS). The US Food and Drug Administration (FDA) has also granted the drug orphan designation for the treatment of hyperinsulinemic hypoglycemia.

There have been previous, positive clinical results from a preceding clinical trial (through Eiger) involving 36 patients with exendin 9-39 in PBH patients across 3 proof-of-concept clinical studies.¹ Eight patients were randomized for a 3.5-hour infusion of exendin 9-39 or placebo in a cross-over design. Endpoints included hypoglycemia and primary. All 8 patients included in the study experienced glucose levels that resembled healthy patients with no observed side effects. None of the 8 patients treated with exendin 9-39 experienced glucose levels that fell below 50 mg/dL, while all 8 of the placebo-administered patients experienced 50 mg/dL and had to be rescued with IV dextrose.

Senior Vice President of Metabolic Disease Lisa Porter, MD, said in a statement that she looks forward to the study. “We are pleased to begin the first multi-center study of exendin 9-39 and dose our first PBH patient in the PREVENT study. Exendin 9-39 is the first potential targeted therapy for PBH, a significant unmet medical need."¹

PBH is a condition in which individuals experience dangerously low postprandial blood glucose levels. Abnormal and overabundant increases in the hormone insulin can lead to severe hypoglycemia (low blood sugar) as well as other morbid outcomes, such as seizures, brain damage, and comas.

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References:

1. “Eiger Announces First Patient Dosed in Phase 2 PREVENT Study of Exendin 9-39 in Patients Suffering from Post-Bariatric Hypoglycemia.” Eiger Biopharmaceuticals, Inc. 26, May 2018.

2. “Exendin 9-39 Phase 1 Intravenous Infusion Study.” Eiger Biopharmaceuticals, Inc. June 2016.