CuraTeQ Biologics announces Phase1 clinical study outcome of BP11 product
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CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, 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.
Dr. Disha Dadke, Associate President and Head R&D, said, “We have initiated a Phase 3 study of our Omalizumab candidate BP11 for the treatment of chronic spontaneous or idiopathic urticaria, which is a presence of hives that are itchy and can last for a number of weeks with no apparent external trigger. The Phase 3 efficacy and safety study is being conducted across multiple sites in seven European countries and in 600 patients with chronic spontaneous urticaria. Additionally, a separate Phase 3 trial in asthma patients is being carried out in the Indian population. CuraTeQ intends to file the Omalizumab biosimilar product in India in 2024 and is on track to file the product in regulated markets in 2025.”
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