Hyruan III Mechanism of Action

Pharmacology: Summary of the Clinical Study: A multicentre randomized, open-label, phase III study to compare the efficacy and safety of Hyruan III (high-molecular-weight hyaluronan) once a week for 3 weeks with Hyal (low molecular-weight hyaluronan) once a week for 3 weeks with Hyal (low molecular-weight hyaluronan) once a week for 5 weeks in patients with the knee osteoarthritis was conducted.
Efficacy result: 1) Primary efficacy variable: The statistical analysis of primary efficacy variable was based on the based on the comparison of improvement in pain intensity on weight bearing in the target knee. The results demonstrated the non-inferiority of Hyruan III injection as compared with Hyal injection for treatment of knee OA.
2) Secondary efficacy variables: WOMAC-Likert assessments: Both OA pain and functional disability, as compared with baseline, the score at each visit was significantly reduced in both treatment groups. Furthermore, chronological comparison of score in each group was also known to be statistically significant.
Patient's global assessment: Although patients of the Hyruan III group reported greater improvement of knee OA, the inter-group difference was not statistically significant.
Investigator's global assessment: Although investigator's assessments indicated greater improvement of knee OA in patients of the Hyruan III group, the inter-group difference was not statistically significant.
Evaluation of knee OA signs (Swelling, tenderness, range of motion, rescue medication usage).
The inter-group difference was not statistically significant.
Safety result: Adverse events: The percentage of patients with one or more adverse events was 68.4% in the Hyruan III group and 62.8% in the Hyal group. Pain at the injection site was the most common adverse event and was observed in a comparable number of patients in both treatment groups: 24 (30.4%) and 25 (32.1%) in the Hyruan III and Hyal groups, respectively. Adverse events observed in ≥5% of patients in at least one of the two treatment groups were: Myalgia (10.1% and 10.3% in the Hyruan III and Hyal groups, respectively), headache (6.3% and 11.5%), upper respiratory infection (7.6% and 3.8%), indigestion (7.6% and 2.6%) and rhinitis (0.0% and 5.1%). The general profile of adverse events was not significantly different between the two treatment groups.
Conclusion: The results of the present study indicate that the efficacy and safety of Hyruan III injection once a week for 3 weeks is comparable to Hyal injection once a week for 5 weeks.