CuraTeQ Biologics announced positive top-line results from its phase-III study of BP11, an investigational biosimilar to Xolair (omalizumab). The study met all primary endpoints, showing comparability to the reference product in patients with Chronic Spontaneous Urticaria (CSU) at the 300 mg dose.

The trial was conducted in 608 patients across approximately 80 sites in seven European countries and India. It evaluated change from baseline in ISS7 (7-point Itch Severity Score) at week 12, the main primary endpoint applicable for both US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals.

“These phase-III 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 Arpitkumar Prajapati, Head—Clinical Development, CuraTeQ Biologics.

Results demonstrated equivalence, with confidence intervals within the predefined margins (-2.5 to 2.0). The co-primary endpoint of relative potency, based on change from baseline in ISS7 at week 12 using a four-point assay, met its criteria, demonstrating parallelism between BP11 and Xolair across dose levels. These outcomes reflect variability, data and efficacy alignment. The results support regulatory submissions targeting CSU, allergic asthma and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

 “BP11 demonstrates comparable efficacy and safety to Xolair, paving the way for patient access to affordable treatment options. We are planning to complete filing of BP11 with both EMA and FDA by the end of Q2 2026,” said Disha Dadke, Head—R&D and Regulatory Sciences, CuraTeQ Biologics.