Danish biotech Gubra touts early win for long-acting amylin in obesity

Two weeks after Boehringer Ingelheim pulled the plug on a partnered obesity programme, Gubra is reporting "positive" Phase I data for its long-acting amylin analogue GUBamy (GUB014295), indicating that the Danish biotech's independent assets may offer promising alternatives.

In the single ascending-dose study, subjects receiving the highest doses (3.5–6.0 mg) achieved approximately 3% weight reduction over six weeks, while the placebo group gained about 1%. The study was conducted in healthy lean and overweight male subjects with a mean body mass index (BMI) of about 26.7 who were randomised into six cohorts treated with either GUBamy or placebo.

"We are very pleased to see that our data confirms the potential of GUBamy as an anti-obesity treatment," said CEO Henrik Blou. "GUBamy was well tolerated, and the very long half-life supports a weekly dosing regimen."

Gubra said the treatment's pharmacokinetic profile revealed a half-life of 270 hours, or 11 days, supporting weekly subcutaneous administration. Adverse events aligned with expectations for the drug class, primarily presenting as gastrointestinal effects including frequent nausea and reduced appetite, with occasional vomiting.

Investors are paying close attention to trial outcomes of amylin-based drugs, which could soon represent a new category in weight-loss therapies. Before the end of the year, Novo Nordisk plans to release data from a large study of CagriSema, a combination of the dual amylin and calcitonin receptor agonist cagrilintide, plus GLP-1 agonist semaglutide, the active ingredient in its popular obesity drug Wegovy. The drugmaker recently reiterated its expectation that the new injection will deliver 25% weight loss.

Meanwhile, Zealand Pharma has its own amylin compound, petrelintide, and is actively seeking partners to advance the treatment to the next development phases.