MBX Biosciences (MBX) Study Result summary

Background and unmet need

• Post-bariatric hypoglycemia (PBH) is a rare, serious complication affecting over 90,000 US patients, with unpredictable severe hypoglycemia and neuroglycopenic symptoms.

• No approved pharmacotherapies exist; current care relies on dietary restrictions, off-label drugs, and surgery, all with limited efficacy and adherence.

• PBH is marked by repeated hypoglycemic episodes due to exaggerated GLP-1 secretion, and its incidence is expected to rise as bariatric surgeries increase.

• MBX 1416 is a long-acting, once-weekly GLP-1 antagonist developed to prevent severe hypoglycemia and improve quality of life for PBH patients.

Study background and objectives

• The phase I trial aimed to assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy adults.

• MBX 1416 is designed for once-weekly dosing, leveraging structural modifications for potency and stability.

• The study included single-ascending dose (SAD), multiple-ascending dose (MAD), and drug-drug interaction (DDI) cohorts.

• MBX 1416 was designed using the proprietary PEPTM platform.

Study design and population

• 69 healthy adults participated: 32 in SAD, 23 in MAD, and 14 in DDI cohorts.

• Dosing regimens included 10 mg, 30 mg, 100 mg, and 200 mg in SAD; 10 mg and 30 mg (single or split) in MAD.

• Demographics were diverse and balanced across cohorts, with mean ages ranging from 35.9 to 41.9 years and representation across age, sex, and ethnicity.