Gubra (GUBRA) Study Update summary

Study background and design

• GUBamy is a novel, long-acting amylin analog designed for obesity treatment, with a balanced receptor profile and solubility at neutral pH, enabling once-weekly subcutaneous dosing and potential co-formulation with other anti-obesity agents.

• The Phase 1a single ascending dose (SAD) trial was randomized, double-blind, placebo-controlled, and conducted at a single site in the UK, enrolling 48 healthy, slightly overweight men aged 18–55 with BMI 22–32 kg/m², divided into cohorts receiving 0.5–6.0 mg GUBamy or placebo.

• Baseline characteristics were balanced across groups, with mean age 32–48 years and mean BMI 24.8–28.6 kg/m².

• Primary endpoints were safety and tolerability; secondary and exploratory endpoints included pharmacokinetics, pharmacodynamics, and body weight change.

Safety and tolerability

• GUBamy was well tolerated, with most adverse events mild, transient, and primarily gastrointestinal, including frequent nausea, reduced appetite, and occasional vomiting, increasing with higher doses.

• No severe or serious adverse events occurred; all subjects completed the study.

• All adverse events resolved during the study, most within a few days.

Pharmacokinetics

• GUBamy demonstrated dose-proportional pharmacokinetics, with a consistent half-life of approximately 11 days across all doses, supporting once-weekly dosing.