GlycoNex Initiates Phase 3 Trial for Denosumab Biosimilar SPD8 in Osteoporosis
Key Insights
GlycoNex (search) has dosed the first patient in a Phase 3 clinical trial for SPD8, a biosimilar of denosumab, targeting osteoporosis (search) treatment.
SPD8, co-developed with Mitsubishi Gas Chemical Company (search), aims to offer a cost-effective alternative to denosumab, with results expected in Q2 2026.
Phase 1 trials confirmed SPD8's safety and pharmacokinetic equivalence, supported by a manufacturing agreement with EirGenix for large-scale production.
GlycoNex (search) Inc. has announced the commencement of its Phase 3 clinical trial for SPD8, a biosimilar of denosumab, with the first patient dosed. This pivotal trial aims to evaluate SPD8 as a treatment for osteoporosis (search). Unblinded results from the study are anticipated in the second quarter of 2026.
SPD8 is being co-developed with Mitsubishi Gas Chemical Company (search) (MGC) as a biosimilar to denosumab (Xgeva and Prolia), a widely prescribed therapy for preventing skeletal-related events in patients with bone metastases from solid tumors and for treating osteoporosis (search). Phase 1 clinical trials have previously confirmed SPD8's safety profile and pharmacokinetic equivalence to the reference drug, paving the way for this advanced stage of development. To ensure sufficient supply for the trial and regulatory submissions, GlycoNex (search) has partnered with EirGenix, Inc., Taiwan's largest CDMO, for the large-scale manufacturing of SPD8.
Addressing the Growing Demand for Osteoporosis Treatment
"The initiation of this Phase 3 trial and the dosing of the first patient are significant achievements in the development of SPD8," stated Dr. Mei-Chun Yang, CEO of GlycoNex (search). "As the demand for osteoporosis (search) treatments continues to grow, we are committed to providing affordable and effective options that improve patient care worldwide."
Denosumab, marketed as Xgeva and Prolia, is a leading treatment for bone loss and cancer-related skeletal complications. In 2023, global sales of denosumab products reached USD 6.1 billion, underscoring the need for cost-effective biosimilar alternatives. With the prevalence of osteoporosis (search) on the rise, particularly among the aging population in Asia, SPD8 is strategically positioned to address this increasing demand.
Expanding Beyond Osteoporosis: GlycoNex's Oncology Pipeline
In addition to the advancement of SPD8, GlycoNex (search) is actively expanding its oncology pipeline. The company's lead monoclonal antibody, GNX102, has successfully completed Phase 1 clinical trials, demonstrating a favorable safety and tolerability profile. GlycoNex is also preparing GNX102 for further development as an antibody-drug conjugate (ADC) through a collaboration with Sterling Pharma Solutions. These initiatives highlight GlycoNex's commitment to developing impactful therapies for a range of global health challenges.