First Patients Dosed in Phase 3 Study of Natalizumab Biosimilar

On Monday, Polpharma Biologics announced that it has randomized the first patients in its phase 3 study of PB006, a proposed natalizumab biosimilar, and patients have begun to receive the study medication.

The phase 3 clinical trial is being conducted in 7 countries in Europe and elsewhere. The first participants were enrolled in a site in Poland.

Natalizumab (Tysabri) is a disease-modifying therapy being used to treat relapsing-remitting multiple sclerosis (MS) as well as Crohn disease. The monoclonal antibody is a selective adhesion molecule inhibitor that binds to α₄-integrin.

The proposed biosimilar is being developed by the Poland-based Polpharma and will, if eventually authorized, be commercialized by Sandoz, which the companies announced in September 2019.

The multicenter, randomized, parallel arm, double-blind study of the proposed biosimilar will enroll approximately 260 patients with relapsing-remitting MS who will be randomized to receive 12 doses, every 4 weeks, of either PB006 or the reference natalizumab.

The primary outcome measure of the study is the cumulative number of new active lesions from baseline to week 24. Brain magnetic resonance imaging will be performed at study sites to assess the number of new lesions per patient.

Secondary outcomes include the cumulative number of new active lesions at week 48, a comparison of annualized relapse rates at weeks 24 and 48, the number of persistent lesions at weeks 24 and 48, and evaluations of safety and immunogenicity, among others.

The study is expected to be completed in August 2021.

In addition to its natalizumab biosimilar, Polpharma also developed, together with partner Bioeq, a ranibizumab biosimilar (FYB201) to which Coherus BioSciences recently acquired rights. The drug maker is also in technical development phases with proposed biosimilars of ustekinumab (Stelara), vedolizumab (Entyvio), and 3 undisclosed molecules targeting oncology indications.