GlycoNex plans to initiate Phase 3 clinical program of SPD8 in osteoporosis, targeting a multibillion USD global market opportunity

August 16, 2024 – New Taipei City, Taiwan – 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 performance.

“The successful completion of the SPD8 Phase 1 study is an important milestone in the ongoing development of a denosumab biosimilar for the treatment of osteoporosis and GlycoNex's overarching mission to make advanced biologic therapies more accessible and affordable,” said Mei-Chun Yang, CEO of GlycoNex. “As we move forward to Phase 3, we remain committed to delivering a safe and effective, high-quality denosumab biosimilar that offers the potential to improve patient outcomes, while reducing the financial burden on osteoporosis patients and healthcare systems around the world.”

Global sales of two denosumab-containing drugs amounted to 4 billion USD and 2.1 billion USD respectively in 2023. With the increasing elderly population and growing awareness of osteoporosis risks, the market for denosumab continues to expand. In addition to the Japanese market, GlycoNex is actively pursuing global development plans, aiming to provide improved treatment options to people with osteoporosis worldwide.

GlycoNex, in collaboration with Mitsubishi Gas Chemical (MGC), is advancing the development and production of SPD8. Recently, MGC and GlycoNex successfully completed the Phase 1 clinical trial of SPD8 in Japan, marking a significant milestone in its development.

Ms. Yang concluded: “We are energized by the opportunity to advance SPD8 and potentially add an additional revenue stream to GlycoNex’s business, while showcasing our expertise in engineering monoclonal antibodies (mAbs) for a host of disease indications. This includes the continued development of our GNX102 antibody-drug conjugate (ADC) product, which combines a proprietary mAb and cytotoxic drug therapies for the treatment of multiple, high-incidence cancers.”