CuraTeQ Biologics Pvt Ltd, a wholly owned subsidiary of Aurobindo Pharma Ltd, has announced positive top-line results from its Phase 3 clinical study of BP11, an investigational biosimilar to Xolair (omalizumab).
Study meets primary endpoints in CSU patients
According to the company, the study successfully met all primary endpoints, demonstrating high comparability with the reference product in patients suffering from chronic spontaneous urticaria (CSU) at the 300 mg dose.
Large-scale multi-country clinical trial
The Phase 3 trial was conducted on 608 patients across nearly 80 sites spanning seven European countries and India. The study evaluated the change from baseline in ISS7 (7-point Itch Severity Score) at Week 12, which serves as the primary endpoint for both US FDA and European Medicines Agency (EMA) approvals.
Strong efficacy and statistical equivalence
Results showed precise equivalence between BP11 and the reference drug, with tight confidence intervals falling well within the predefined margins of -2.5 to 2.0.
The co-primary endpoint, relative potency based on ISS7 score changes at Week 12 using a 4-point assay, was also successfully met, confirming parallelism between BP11 and Xolair across dose levels.
The findings underscore controlled variability, robustness of clinical data, and strong alignment in efficacy between the two products.
Regulatory filings planned across key markets
The positive outcomes support planned regulatory submissions for multiple indications, including CSU, allergic asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP).
Results validate firm’s clinical strategy
“These Phase 3 results with narrow confidence intervals validate our clinical strategy and the team’s execution in delivering a high-quality biosimilar. Detailed results will be submitted for regulatory review and presented at upcoming medical conferences,” said Dr Arpitkumar Prajapati, head of clinical development.
Dr Disha Dadke, head of R&D and regulatory sciences, added, “BP11 demonstrates comparable efficacy and safety to Xolair, paving the way for improved patient access to affordable treatment options. We aim to complete regulatory filings with both the EMA and the US FDA by the end of Q2 2026.”