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GlycoNex Announces Last Patient Dosed in Phase 3 Trial of SPD8, a Denosumab Biosimilar for Osteoporosis
GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the last patient has received the final dose in its Phase 3 clinical study of SPD8, a biosimilar to denosumab for the treatment of osteoporosis. Developed in collaboration with Mitsubishi Gas Chemical (MGC), SPD8 is designed to address complications associated with bone metastases in patients with solid tumors and osteoporosis-related conditions. Dosing of the final patient marks a significant milestone for the program,
About this update from Glyconex, Inc.
[{"type":"text","content":"Topline data expected in second quarter 2026","length":44,"tagName":"p","attribs":{}},{"type":"text","content":"NEW TAIPEI CITY, Taiwan, Oct. 29, 2025 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the last patient has received the final dose in its Phase 3 clinical study of SPD8, a biosimilar to denosumab for the treatment of osteoporosis. Developed in collaboration with Mitsubishi Gas Chemical (MGC), SPD8 is designed to address complications associated with bone metastases in patients with solid tumors and osteoporosis-related conditions. Dosing of the final patient marks a significant milestone for the program, positioning GNX to report top-line results from the study in the second quarter of 2026.","length":648,"tagName":"p"},{"type":"image","alt":"GlycoNex, Inc. (PRNewsfoto/GlycoNex, Inc.)","displaySize":"","headline":null,"caption":"GlycoNex, Inc. (PRNewsfoto/GlycoNex, Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":377,"url":"https://media.zenfs.com/en/prnewswire.com/72f55fbc984af5a9b79660de98aaf4d4"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/AMKCcOpK.0h0z9PlxCRtcQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTY2NDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/72f55fbc984af5a9b79660de98aaf4d4","width":400,"height":377}},"href":"https://mma.prnewswire.com/media/2420764/GlycoNex_Inc.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The randomized, multicenter, double-blind, parallel-group study is evaluating the pharmokinetic equivalence, efficacy, and safety of SPD8 compared to denosumab in postmenopausal women with primary osteoporosis from solid tumors . The resulting data generated will support global registration. The SPD8 program reflects GNX's broader strategy of leveraging its expertise in complex antibody manufacturing to deliver high-quality biosimilars in parallel with its efforts to develop novel glycan-directed antibody-drug conjugates.","length":531,"tagName":"p"},{"type":"text","content":""Achieving 'last patient, last dose' in our SPD8 Phase 3 study represents a critical milestone for GlycoNex," said Dr. Mei-Chun Yang, CEO of GlycoNex. "With the trial now moving into its final phase of analysis, we are focused on advancing SPD8 toward regulatory submission and deli...