02:32 ETBrightGene Announces Positive Topline Phase 1 Results of Oral BGM0504 in Obesity in China and the United States

BGM0504 shown to be generally well tolerated Overall safety, pk, and efficacy profile supports once-daily oral dosing , /PRNewswire/ -- BrightGene Bio-Medical Technology Co., Ltd. (SSE: 688166, "BrightGene" or "the Company") today announced positive topline results from Phase 1 clinical studies of BGM0504, an investigational oral GLP-1/GIP dual receptor agonist, in adult participants in China and the United States, including healthy volunteers and individuals with overweight or obesity. Across both studies, BGM0504 was generally well tolerated, with no serious adverse events. Gastrointestinal adverse events, when observed, were predominantly mild to moderate in severity and transient, consistent with the known profile of this class. Preliminary efficacy results based on an intent-to-treat analysis showed meaningful reductions in body weight, with mean body weight reductions ranging from 1.0% to 5.6% after four weeks of treatment in the China study and from 2.7% to 8.2% after five to eight weeks of treatment in the U.S. study. The China Phase 1 study (CTR20253763 / NCT07239973) was a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGM0504 in healthy participants and non-diabetic individuals with overweight or obesity. A total of 75 participants were enrolled and completed the study. BGM0504 was administered once daily at doses ranging from 10 mg to 80 mg for four weeks. The compound was generally well tolerated across all dose levels, with no serious or unexpected adverse events reported. Gastrointestinal adverse events were mostly mild (Grade 1) and transient. Pharmacokinetic analyses showed that steady-state exposure was achieved after approximately two to three weeks of dosing and that exposure increased in a generally dose-proportional manner. After four weeks of treatment, participants receiving BGM0504 demonstrated reductions in body weight relative to baseline, with mean reductions ranging from 1.0% to 5.6% (least squares mean) across dose groups. The U.S. Phase 1 study (NCT07166081) was a randomized, placebo-controlled, multiple ascending dose trial evaluating safety, tolerability and preliminary efficacy of BGM0504. A total of 80 participants were enrolled, including 64 who received BGM0504 and 16 who received placebo. Participants received once-daily dosing across dose levels ranging from 20 mg to 80 mg, with treatment durations of five to eight weeks depending on dose cohort and at least four weeks of dosing at the target dose. BGM0504 was generally well tolerated, with no serious adverse events reported. The most commonly observed adverse events were gastrointestinal in nature, were generally mild to moderate, and were transient. Preliminary efficacy analyses demonstrated does response in weight reduction, with mean body weight reductions ranging from 2.7% to 8.2% (least squares mean) after five to eight weeks of treatment. Detailed results from these studies are expected to be presented at a scientific conference later this year. BGM0504 Program Overview BGM0504 is being developed in both oral and subcutaneous formulations as part of the Company's broader strategy in obesity and related metabolic diseases. The subcutaneous formulation is at an advanced stage of development, with China Phase 2 studies and a U.S. bridging study completed and multiple Phase 3 studies currently ongoing. The data disclosed in this announcement are based on preliminary analyses of ongoing clinical studies. As additional data become available and further analyses are conducted, the results and interpretations may be subject to change. BGM0504 remains an investigational drug and has not been approved for marketing in any country. Drug development involves substantial risks and uncertainties, and clinical trial results may not be predictive of future outcomes. Further studies are required to establish the safety and efficacy of BGM0504. SOURCE BrightGene