GlycoNex Begins Phase 3 Trial of SPD8 Biosimilar for Osteoporosis Treatment

GlycoNex Initiates Phase 3 Clinical Trial for SPD8

GlycoNex, Inc., a clinical-stage biotechnology firm based in New Taipei City, Taiwan, has reached a crucial milestone in the development of its denosumab biosimilar, SPD8, with the announcement of the first patient dosed as part of a Phase 3 clinical trial. This trial is set to play a pivotal role in evaluating the bioequivalence and effectiveness of SPD8 as a treatment option for osteoporosis. Results from the trial are anticipated in the second quarter of 2026.

Denosumab is widely utilized in medical practice under the brand names Xgeva and Prolia, particularly for preventing skeletal-related complications in patients dealing with bone metastases and those suffering from osteoporosis. The global sales of denosumab reached a striking USD 6.1 billion in 2023, underscoring the vast market potential for biosimilar alternatives like SPD8.

The development of SPD8 is being executed in collaboration with Mitsubishi Gas Chemical Company (MGC). Prior Phase 1 clinical trials have confirmed that SPD8 holds comparable safety and pharmacokinetic profiles to its reference drug, laying the groundwork for this next critical step in clinical development. To facilitate this trial and enhance regulatory submissions, GlycoNex has partnered with EirGenix, Inc., the largest Contract Development and Manufacturing Organization (CDMO) in Taiwan, to ensure large-scale production of SPD8.

Dr. Mei-Chun Yang, CEO of GlycoNex, expressed optimism regarding this trial, emphasizing its significance in the ongoing quest to provide safe, affordable, and effective treatments for osteoporosis as the population ages and the prevalence of osteoporosis continues to rise, particularly in Asia.

Furthermore, GlycoNex is not solely focused on SPD8. The company is progressing its oncology pipeline, particularly the lead monoclonal antibody GNX102, which has also completed its Phase 1 trials demonstrating strong safety and tolerability. GlycoNex is preparing this antibody for future development into an antibody-drug conjugate (ADC) in partnership with Sterling Pharma Solutions. Such initiatives highlight GlycoNex's commitment and capability in addressing pressing health challenges globally.

As a company dedicated to creating glycan-directed cancer immunotherapies, GlycoNex is spearheading innovative approaches in biomedical science with an impressive arsenal of therapies designed to deliver efficacy while minimizing side effects. Through its ongoing efforts and strategic expansions, GlycoNex is not merely enhancing its product portfolio but also contributing significantly to the advancement of patient care on a global scale.

For more information on GlycoNex and its innovative therapies, you can visit their official page at GlycoNex Official Website.