Gubra’s once-weekly obesity candidate was tied to 3% weight loss during a six-week phase 1 trial, with a single injection also linked to weight reduction.
The single ascending dose trial enrolled lean or overweight men with an average BMI of 26.6. Study participants were then randomized into six groups and received either placebo or Gubra’s long-acting amylin analog, dubbed GUBamy.
This early portion of the trial measured GUBamy’s safety and tolerability, with Gubra reporting that the investigational treatment was well tolerated. The majority of events were gastrointestinal, mild and transient, according to the Danish biotech.
Effects on body weight were seen beginning on the third day after dosing and were sustained throughout the six weeks. Mean body weight reduction in the three highest dose groups (3.5 mg-6 mg) reached about 3%, compared to about 1% weight gain in the placebo group.
GUBamy had an 11-day half-life and a pharmacokinetic profile that supports once-weekly dosing, according to Gubra.
A single dose of GUBamy also reduced body weight in a dose-dependent manner for the duration of the study, the company said.
Gubra is expected to host a presentation about the data Nov. 14.
The public biotech continues to run a phase 1b multiple ascending dose study for GUBamy, with an interim readout expected in the first half of 2025.
GUBamy is part of the investigational amylin field, a burgeoning landscape that includes Novo Nordisk’s CagriSema, a combination of long-acting amylin analog cagrilintide and GLP-1 agonist semaglutide. The Big Pharma is currently testing the obesity treatment out in phase 3 trials, with a readout expected before the end of the year.
Other players include Metsera, a newly emerged weight loss biotech that just announced a $215 million series B fundraise Nov. 13.