The Food and Drug Administration (FDA) has granted Fast Track designation to telitacicept (RC18; RemeGen) for the treatment of systemic lupus erythematosus (SLE).

Telitacicept is a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein designed to inhibit the development and survival of plasma cells and mature B cells, preventing the formation of autoantibodies. It works by binding to the cell-signaling molecules BLyS (B lymphocyte stimulator) and APRIL (a proliferation-inducing ligand). 

The designation is supported by data from a multicenter, double-blind, placebo-controlled phase 2b study that evaluated the efficacy and safety of telitacicept in patients with moderate to severe SLE. Patients were randomized to receive telitacicept 80mg, 160mg, or 240mg, or placebo in addition to standard therapy (eg, corticosteroids, antimalarials, NSAIDs, immunosuppressive, or immunomodulator therapy) for 48 weeks. The primary end point was change from baseline in the SLE Responder Index Response rate, defined as a greater than 4-point reduction.

Findings from the study showed that telitacicept met the primary end point with a statistically significant proportion of patients achieving clinically meaningful disease activity improvement with telitacicept 80mg (71%; P <.001), 160mg (68.3%; P <.001), and 240mg (75.8%; P <.001) vs placebo (33.9%). 

With regard to safety, the most common treatment-related adverse events included upper respiratory tract infection and injection site reactions.

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The Company is currently enrolling patients in a phase 3 study of telitacicept for the treatment of moderate to severe SLE. Additionally, the Company is assessing telitacicept across other diseases, including rheumatoid arthritis and multiple sclerosis.

For more information visit remegen.com.