BrightGene Pharmaceutical has scored an early win in its push to topple the big beasts of the GLP-1 field. The biotech linked its challenger to bigger reductions in blood sugar than Novo Nordisk’s semaglutide, the ingredient in its obesity and diabetes franchise comprising Wegovy, Ozempic and Rybelsus, giving the company momentum as it barrels toward a readout from a head-to-head trial against Eli Lilly’s tirzepatide.
China-based BrightGene shared phase 2 results on its GLP-1/GIP receptor agonist BGM0504 at the 85th American Diabetes Association Scientific Sessions. One study compared three doses of the drug candidate to placebo and semaglutide in 67 patients with Type 2 diabetes in China. HbA1c, a measure of blood sugar, was between 7.1% and 10% at baseline.
BrightGene saw dose-dependent reductions in HbA1c of up to 2.48% on BGM0504 after 12 weeks, compared to 1.43% on semaglutide and 0.28% on placebo. The placebo comparison was double blind, but the semaglutide cohort was open label.
The biotech reported “similar results” on secondary endpoints, including body weight. Participants had a body mass index of between 19.5, in the healthy range, and 35, the cusp of class 1 and 2 obesity, at baseline.
BrightGene’s press release lacked a detailed look at adverse events. The biotech said most treatment-emergent adverse events “were grade 1 or 2 during the rapid titration stage and gradually tolerated after reaching the target dose.” The most common treatment-related gastrointestinal adverse events were diarrhea, nausea and abdominal distension, side effects that are associated with other GLP-1 drugs.
The biotech shared data from another phase 2 trial that compared BGM0504 to placebo in 120 people with overweight or obesity in China. After a two- to six-week titration phase, participants received BGM0504 once a week for 24 weeks. The trial ended with a two-week follow-up. BrightGene reported weight loss of 10.77% to 19.78% across the three BGM0504 doses.
Bigger tests are coming up. BrightGene is pitting BGM0504 against tirzepatide, the rival GLP-1/GIP drug in Lilly’s Mounjaro and Zepbound, in a phase 2 obesity trial that is scheduled to wrap up next year. The biotech is also enrolling patients in three phase 3 trials in China. Two of the trials are targeting Type 2 diabetes. The third study is enrolling patients who are overweight or with obesity.