EirGenix, Inc. | MedPath

GlycoNex Initiates Phase 3 Trial for Denosumab Biosimilar SPD8 in Osteoporosis

5 months ago

• GlycoNex has dosed the first patient in a Phase 3 clinical trial for SPD8, a biosimilar of denosumab, targeting osteoporosis treatment. • SPD8, co-developed with Mitsubishi Gas Chemical Company, 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 is also advancing its oncology pipeline, including GNX102, a monoclonal antibody, currently being developed as an antibody-drug conjugate.