Aurobindo Pharma arm announces successful Phase 1 clinical study outcome of their BP11 product

Hyderabad: CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, has announced that their Omalizumab biosimilar candidate BP11 has met the Phase 1 trial end points vis-à-vis the EU and US sourced reference product Xolair.

The PK/PD trial was conducted in 165 healthy volunteers in Australia and New Zealand.

“The primary objective was to prove pharmacokinetic (PK) equivalence between BP11, US and EU sourced Xolair. 165 healthy volunteers were randomized to receive either BP11 or EU or US licensed Omalizumab via subcutaneous route of administration. Results of both primary parameters, i.e. maximum serum concentration (Cmax) and area under concentration-time curve from time zero to infinity (AUC0-inf), were contained within 80- 125% bioequivalence limit demonstrating PK equivalence between BP11 and both US and EU sourced Xolair. BP11 also had similar IgE levels to Xolair demonstrating comparable pharmacodynamic profile versus US and EU sourced Xolair. The safety and immunogenicity profiles were also found comparable versus the originator’s product,” said Dr. Arpit Prajapati, Head of Clinical Sciences at CuraTeQ Biologics.