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 long half-life, enabling once-weekly subcutaneous dosing.

• The Phase I single ascending dose (SAD) study was randomized, double-blind, placebo-controlled, and included 48 healthy, slightly overweight male subjects with a mean BMI of 26.65, divided into six cohorts.

• Doses ranged from 0.5 mg to 6 mg, with primary endpoints of safety and tolerability, and secondary/exploratory endpoints of pharmacokinetics, pharmacodynamics, and body weight change.

Key results and safety findings

• GUBamy was well tolerated, with adverse events mainly mild, transient, and gastrointestinal, including frequent nausea, reduced appetite, occasional vomiting, and injection site pain, mostly at higher doses.

• No severe or serious adverse events occurred, all subjects completed the study, and all adverse events resolved during the study, most within a few days.

Pharmacokinetics and efficacy

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

• Dose-dependent, sustained body weight reduction was observed in the three highest dose groups (3.5–6.0 mg), with mean reductions of 1.8% to 3.2% over six weeks, compared to a 0.5–1% weight gain in placebo.

• Weight loss effect was evident from day four and maintained throughout the study period.