HYDERABAD:
Aurobindo Pharma
Ltd on Friday informed the bourses that its wholly owned subsidiary,
CuraTeQ Biologics
Pvt Ltd’s
Omalizumab
biosimilar candidate – BP11 – has met the Phase-1 trial end points as compared to the US and EU sourced reference product Xolair. Omalizumab is a monoclonal antibody used for the treatment of asthma and hives.
Aurobindo said
CuraTeQ
intends to take up two Phase-3 studies across Europe and India and plans to seek regulatory approval for the Omalizumab biosimilar product in India in 2024 and in regulated markets in 2025.
The PK/PD Omalizumab trial was conducted in 165 healthy volunteers in Australia and New Zealand with a primary objective of proving pharmacokinetic (PK) equivalence between BP11, US and EU sourced Xolair,
Aurobindo
Pharma said in a regulatory filing.
“The 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, which is the 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,” said CuraTeQ Biologics’ head of clinical sciences Dr Arpit Prajapati.
“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,” Prajapati added.
CuraTeQ Biologics associate president and R&D head Dr Disha Dadke said the company has now initiated a Phase-3 study of 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 on 600 patients with chronic spontaneous urticaria. Apart from this, a separate Phase-3 trial is being carried out in asthma patients 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,” she added.
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