Alexey Boyko
The BCD-132 and BCD-054 (JSC BIOCAD, Russia) are novel immunomodulating therapeutic options for relapsing form of multiple sclerosis (MS) treatment. The BCD-054 is a conjugate of recombinant human interferon β1a and linear polyethylene glycol (PEG) with a molecular weight of 30kDA. Such conjugation decreases renal clearance, increases half-life of drug and, consequently, allows to prolong the duration of action and reduce the frequency of injections compared with non-pegylated forms of interferon. The interim 20-week results of BCD-054 III phase study showed significant reduction in brain MRI disease activity on PEG interferon β1a therapy compared with placebo. It was proven, what two studied doses of BCD-054 superior to placebo for the primary efficacy endpoint represented by combined unique active (CUA) lesion counts. Assessment of clinical performance demonstrated the reduction of relapse rate: BCD-054 180 μg - 10, 62%, BCD-054 240 μg - 6,14%, low dose interferon β1a (LIB) - 15,93%, placebo - 15,79%. Another potential treatment of MS is BCD-132, an innovative the 3rd generation humanized afukosylated anti-CD20 antibodies. It has increased affinity for FcγRllla, thereby effectively induces antibody-dependent cytotoxicity and antibody dependent phagocytosis. Direct strictly specific effect of BCD-132 on B lymphocyte in a wide range of doses (100-1000 mg) was established by dynamic assessment of such cells lever in phase I clinical trial after intravenous administration of increasing doses in two dosage regimens. The obtained data shows that BCD-132 has an expected pharmacodynamic effect of long-term depletion of CD19+ and CD20+ B cell lineage and an acceptable safety profile when used to treat patients with MS in all studied doses.
