Taiwanese biotechnology company GlycoNex has reported positive results from a Phase I clinical trial of its denosumab biosimilar, SPD8.
Conducted in collaboration with Mitsubishi Gas Chemical (MGC), the Phase I trial enrolled healthy postmenopausal women and met its primary endpoint of clinical pharmacokinetic equivalence.
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The trial confirmed that SPD8’s pharmacokinetic profile, safety and pharmacodynamics were comparable to those of the reference biologic, denosumab.
GlycoNex is now preparing to move the drug into Phase III clinical trials, which are expected to begin in the fourth quarter of this year.
The upcoming trials will evaluate SPD8’s efficacy, safety and immunogenicity in a larger patient population with osteoporosis.
GlycoNex and MGC are also advancing the drug’s development and production, having recently successfully completed a Phase I clinical trial in Japan.
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By GlobalDataGlycoNex CEO Mei-Chun Yang said: “The successful completion of the SPD8 Phase I 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.
“As we move forward to Phase III, 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.”
GlycoNex is engaging with regulatory authorities to ensure the trial design meets all necessary requirements.
The company is also looking beyond the Japanese market, with plans to make SPD8 available worldwide to provide improved treatment options for osteoporosis.
The global market for denosumab has increased in recent years, with two drugs containing denosumab achieving total sales of $4bn and $2.1bn respectively last year.
Yang added: “We are energised 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 for a host of disease indications.”
