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

Written By : Susmita Roy |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-18T13:30:30+05:30 | Updated On 20 March 2024 2:27 PM IST

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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.

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.”

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

curateq biologicsaurobindo pharmaaurobindo pharma newsomalizumabBP11xolair

Susmita Roy

Mpharm (Pharmacology)

Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751