China-based pharmaceutical company Bio-Thera Solutions has advanced its monoclonal antibody BAT6026 into a Phase Ia/IIb study to treat patients with atopic dermatitis.
The trial (NCT06094179) has dosed its first patient and aims to enrol 126 atopic dermatitis patients who hadn’t responded well to previous topical treatments or were unable to use them.
The Phase Ib double-blind, placebo-controlled study will involve three dose groups, followed by a Phase IIa randomised double-blind study. The primary endpoint will assess the safety and effectiveness of BAT6026, aiming for a 75% reduction in eczema severity by week 16, after four treatment cycles. Additionally, the Phase IIa study aims to determine the optimal dose for a subsequent Phase III trial.
BAT6026 targets OX40 – a crucial molecule in autoimmune and inflammatory conditions due to its role in immune response regulation – blocking its interaction with OX40L to halt T-cell activation and proliferation. It also selectively eliminates activated OX40+ T cells through an enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) effect. Bio-Thera anticipates that in addition to potentially treating atopic dermatitis, the drug will address various inflammatory diseases, including those involving Th2 cells.
According to a report on GlobalData’s Pharma Intelligence Center, the global atopic dermatitis market is forecast to generate $24.4bn in 2030, increasing at an annual compound growth rate (CAGR) of 7.91% from $11.4bn in 2020.
GlobalData is the parent company of Clinical Trials Arena.
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BAT6026 is under investigation in a separate Phase I trial (NCT05105971) in solid tumour patients in China. The candidate was previously investigated in another Phase I study (NCT05109650) to treat patients with solid tumours, but the company voluntarily terminated the trial citing high costs.
In addition to novel drugs, Bio-Thera also has biosimilars under its belt. In 2021, Bio-Thera and Biogen entered an agreement to develop, manufacture and commercialise Bio-Thera’s anti-interleukin-6 (IL-6) receptor monoclonal antibody BAT1806 – a biosimilar referencing Roche’s Actemra (tocilizumab). The biosimilar gained a US Food and Drug Administration approval for the drug, named Tofidence (tocilizumab-bavi, BIIB00) in September 2023. Bio-Thera had received $30m from Biogen on the Phase III trial of achieving satisfactory results.