SINGAPORE / B3C newswire / -- Prestige BioPharma (herein, Prestige) announced positive results from a Phase I clinical trial (SAMSON-I) evaluating the pharmacokinetics (PK), safety and immunogenicity of biosimilar candidate HD204 to Avastin (bevacizumab).
SAMSON-I is a double-blind, randomized, 3-arm, parallel group study to demonstrate the equivalent pharmacokinetic properties of a single intravenous dose of HD204, US-licensed Avastin and EU-licensed Avastin. A total of 119 healthy male volunteers aged 18-50 years old received a single infusion IV dose of 1mg/kg of study drug and monitored for 71 days.
The primary objective was to establish pairwise PK similarity between all 3 drugs by evaluating the area under the concentration curve from time zero to infinity (AUC0–inf) as its primary endpoint. The 90% CI of the ratio of geometric means of log-transformed AUC0-inf is used to assess bioequivalence between the test and reference using the bioequivalence interval of 80.00% to 125.00%. Bioequivalence is declared if the 90% CI for the ratio falls within 80.00% and 125.00% for the primary PK parameter AUC0–inf for the comparisons: HD204 versus EU-Avastin, HD204 versus US-Avastin. The analysis is repeated for secondary parameters Cmax and AUC0-last as well.
Results have indicated that the 90% CIs for the ratio of the geometric means of HD204 to US-Avastin, HD204 to EU-Avastin, and EU-Avastin to US-Avastin were all within the acceptance interval of 80.00% to 125.00% for AUC0–inf, AUC0-last, and Cmax thus demonstrating equivalency PK properties for all three treatments.
There are no notable differences between all 3 drug products in terms of vital signs, electrocardiograms (ECGs) or laboratory tests. No safety signals were observed in this study and no positive anti-drug antibodies were observed in the HD204 group.
Overall, the study demonstrated that HD204 is bioequivalent to both US-licensed Avastin and EU-licensed Avastin after a single IV infusion at 1mg/kg.
Dr. Lisa Park, CEO of Prestige BioPharma, commented that “our top-line Phase I results for HD204 reflect Prestige’s commitment to providing millions of patients with greater access to high-quality, safe, affordable treatment. We also look forward to further progress in the Phase III global clinical study of HD204.”
Currently, Prestige BioPharma is performing a global Phase III study, SAMSON-II in patients with metastatic or re-current non-squamous non-small cell lung cancer. Prestige plans for filing with European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in 2020.
These top-line positive results data will be presented at an upcoming scientific conference, ESMO 2019 being held September 31 – October 1, 2019 in Barcelona, Spain.
Global Communication Team
Ms. Felicia Ang