BioGend Therapeutics announced on the 15th that its bone growth factor (BiG001) demonstrated positive results in a Phase I/II clinical trial conducted jointly in Taiwan and the United States for patients with open tibial fractures requiring bone grafting. BioGend Chairman Te-Li Chen stated that the potential applications of the bone growth factor also include alveolar bone augmentation and lumbar interbody fusion. The findings from this study provide a solid basis for selecting the dosage to be used in upcoming Phase III clinical trials, which will be carried out across multiple countries alongside ongoing discussions with international licensing partners.
BiG001 is a combination product consisting of an osteoinductive growth factor drug (Osteoinductive Factor, OIF; recombinant human bone morphogenetic protein-2, rhBMP-2) and a bone substitute material, β-tricalcium phosphate (β-TCP). The primary objective of the study was to evaluate the overall efficacy of three dosing levels—low (1.5 mg OIF/g β-TCP), medium (2.0 mg OIF/g β-TCP), and high (3.0 mg OIF/g β-TCP)—to inform Phase III dose selection, with autologous bone grafts serving as the control group.
A total of 35 subjects were enrolled in the trial. The primary endpoint was the overall efficacy rate, which included both effectiveness and safety indicators, evaluated within 30 weeks post-surgery. The overall efficacy rates at 30 weeks for the low-, medium-, and high-dose BiG001 groups and the autologous bone graft group were 80%, 54.5%, 100%, and 40%, respectively, with no statistically significant difference among the three BiG001 dosing groups (p=0.0713). By 52 weeks post-surgery, the overall efficacy rates had improved to 90%, 81.8%, 100%, and 80% (p=0.3582), demonstrating that all three BiG001 dosing regimens achieved healing outcomes comparable to autologous bone grafts.
In terms of bone healing time and rate, BiG001 also showed clear advantages. Radiographic evaluations revealed median bone healing times of 11.5, 7, 6, and 11.4 weeks for the low-, medium-, and high-dose BiG001 groups and the autologous bone graft group, respectively—indicating that the medium- and high-dose BiG001 groups achieved earlier bone healing than the control group.
When compared with the clinical results of INFUSE, a commercially available BMP-2 product, BiG001 demonstrated superior healing outcomes: 63% healing at 6 weeks, over 90% at 12 weeks, and 97% at the final 52-week follow-up. In contrast, INFUSE showed only an 18% healing rate at 6 weeks and failed to reach 90% even by 52 weeks. Although direct comparison is limited by differences in patient inclusion criteria—BiG001’s subjects had more severe fracture conditions—the results remain clinically meaningful.
Dr. Lin Kai-Cheng, Director of the Division of Fracture and Trauma at the Orthopedic Department of Kaohsiung Veterans General Hospital, shared his experience treating two patients who received BiG001. Both patients suffered from open tibial fractures with bone defects of 8–9 mL due to traffic accidents. Following standard care and BiG001 implantation, both patients achieved excellent recovery, with radiographic bone union observed within three months and high self-reported satisfaction scores.
Regarding safety, limb infection rates are a key concern in open fractures, often correlated with Gustilo classification. Particularly in type IIIA and IIIB fractures, which involve severe soft tissue damage, infection risk is typically high. Among the 30 patients treated with BiG001 in this trial, none of the 24 patients with Gustilo type II or IIIA fractures experienced limb infections. Although three of six patients (3/6) with type IIIB fractures developed infections, the rate did not exceed those reported in the literature, indicating that treatment with BiG001 does not increase infection risk.
Te-Li Chen emphasized that the trial results provide a solid scientific rationale for dose selection in the upcoming Phase III trials. In addition to promoting bone fracture healing, BiG001 also shows potential for applications in alveolar bone augmentation and lumbar interbody fusion. BioGend plans to advance Phase III clinical studies across multiple countries while actively engaging international partners for licensing opportunities.
Resource: 博晟骨生長因子台美I/II期臨床數據正向，多國3期臨床、國際授權同推進
