Cytonics Corporation, a Florida-based private biotechnology company developing biologic therapies for musculoskeletal conditions, announced on Tuesday that the first nine patients in its Phase 1 clinical trial evaluating CYT-108 as a therapy for osteoarthritis have successfully completed the study.
CYT-108 is a recombinant variant of the endogenous alpha-2-macroglobulin (A2M) blood serum protein. The "bait" region of the protein, which serves as a substrate for proteases, was engineered to increase its affinity for specific proteases that are known to play a significant role in the molecular pathogenesis of osteoarthritis.
In the study, all patients received two intra-articular doses of CYT-108, administered on Day 0 and Day 90, with follow-up extending to Day 180. Cytonics said that no drug-related adverse events have been reported, underscoring CYT-108's favourable safety profile.
The Phase 1 randomised, double-blind trial is designed to evaluate the safety, pharmacokinetics and exploratory efficacy of CYT-108 in patients with primary osteoarthritis of the knee. Beyond safety, the study is investigating biomarkers associated with cartilage degradation as well as improvements in pain and joint function. The findings will inform the design of subsequent clinical trials.
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