GlycoNex plans to initiate Phase 3 clinical program of SPD8 in osteoporosis, targeting a multibillion USD global market opportunity NEW TAIPEI CITY, Taiwan , Aug. 19, 2024 /PRNewswire/ -- GlycoNex (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer therapies, today announced the successful completion of a Phase 1 clinical trial of its denosumab biosimilar, SPD8, developed in collaboration with Mitsubishi Gas Chemical Company, Inc. (MGC).
The results enable the company to advance to Phase 3 clinical trials with the aim of offering a cost-effective alternative to the currently available denosumab treatment for osteoporosis. The Phase 1 study, conducted in healthy postmenopausal women, demonstrated that GlycoNex's denosumab biosimilar met the primary endpoint of clinical pharmacokinetic equivalence. The trial confirmed the biosimilar's pharmacokinetic profile, safety, and pharmacodynamics were comparable to the reference biologic, denosumab.
With these positive results, GlycoNex is in the final stages of planning for its Phase 3 clinical program for SPD8, which is expected to commence in Q4 2024. This program will further assess the efficacy, safety, and immunogenicity of SPD8 in a larger patient population with osteoporosis. GlycoNex is working closely with regulatory authorities to ensure the trial design meets all necessary requirements for a comprehensive evaluation of the biosimilar's clinical p.