BP11 (omalizumab biosimilar) / Aurobindo - LARVOL DELTA

Aurobindo arm CuraTeQ successfully wraps up Ph-1 trial for Omalizumab biosimilar (The Times of India) - P1 | N=165 | NCT05053334 | Sponsor: Syneos Health | "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....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..."

Non-US regulatory • P2 data • Regulatory • Asthma

Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (clinicaltrials.gov) - P1 | N=165 | Completed | Sponsor: Syneos Health | Active, not recruiting ➔ Completed

Trial completion

Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (clinicaltrials.gov) - P1 | N=165 | Active, not recruiting | Sponsor: Syneos Health | Recruiting ➔ Active, not recruiting

Enrollment closed

Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (clinicaltrials.gov) - P1 | N=165 | Recruiting | Sponsor: Syneos Health | Trial completion date: May 2023 ➔ Oct 2023 | Trial primary completion date: Apr 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date

BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria (clinicaltrialsregister.eu) - P3 | N=600 | Ongoing | Sponsor: CuraTeQ Biologics Private Ltd.

New P3 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Rheumatology • Urticaria

Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (clinicaltrials.gov) - P1 | N=165 | Recruiting | Sponsor: Syneos Health | Trial completion date: Oct 2022 ➔ May 2023 | Trial primary completion date: Oct 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date