Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®

Summary

This is a multi-center, randomized, parallel arm, double-blind study with a total duration of subjects' participation of 48 weeks. Approximately 260 participants with relapsing-remitting multiple sclerosis will be randomized to receive 12 doses of either PB006 or EU-licensed Natalizumab.

Timeline

Start

2019-10-01

Primary completion

2021-08-23

Completion

2022-02-07

Outcome

Met primary endpoint

paper 95% CI, -0.61 to 0.94 within the prespecified margins of ±2.1). PMID 36689214 ↗

release “the confirmatory Phase III ANTELOPE study in RRMS patients. 6 Both studies met their primary endpoints” polpharmabiologics.com ↗

Publications

• Results Hemmer B, Wiendl H, Roth K, Wessels H, Hofler J, Hornuss C, Liedert B, Selmaj K. Efficacy and Safety of Proposed Biosimilar Natalizumab (PB006) in Patients With Relapsing-Remitting Multiple Sclerosis: The Antelope Phase 3 Randomized Clinical Trial. JAMA Neurol. 2023 Mar 1;80(3):298-307. doi: 10.1001/jamaneurol.2022.5007.
• Chamberlain P, Hemmer B, Hofler J, Wessels H, von Richter O, Hornuss C, Poetzl J, Roth K. Comparative immunogenicity assessment of biosimilar natalizumab to its reference medicine: a matching immunogenicity profile. Front Immunol. 2024 Dec 19;15:1414304. doi: 10.3389/fimmu.2024.1414304. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PB006	Monoclonal antibody	300 mg	Intravenous
Subject	natalizumab	Monoclonal antibody	300 mg	Intravenous

Indications