Idorsia Ltd (SIX: IDIA) today announced that the first patient has been enrolled into a multiple-dose study to evaluate the efficacy and safety of cenerimod, a selective S1P1 receptor modulator for the treatment of adults with systemic lupus erythematosus (SLE).
Idorsia is investigating cenerimod, an oral once-daily tablet in patients with lupus. Cenerimod has the potential to add a distinct mechanism to the treatment armamentarium for this underserved patient population.
Martine Clozel, MD and Chief Scientific Officer, commented:”Cenerimod was selected for development due to its unique properties in experimental models. We believe that a combination of high selectivity for the S1P1 receptor and an attenuated calcium response in endothelial cells are responsible for the excellent preclinical efficacy without bronchoconstrictor or vasoconstrictor side-effects. SLE was selected as the target indication because of the pathogenic role of T and B lymphocytes and antibody production in this disease.”
In the Phase 1 program, cenerimod showed marked and sustained circulating lymphocyte lowering effects. A Phase 2 safety study with cenerimod, which investigated the pharmacodynamics, safety and tolerability of cenerimod in adult patients with SLE, has been conducted. The study enrolled 67 patients to receive either 0.5, 1, 2 or 4 mg/day of cenerimod or placebo over a treatment period of 12 weeks. The results of the study showed that cenerimod induces a dose-dependent, sustained reduction in circulating lymphocyte counts that was reversible after treatment discontinuation. Cenerimod was well tolerated at all dose levels. The occurrence of adverse events was similar in all five treatment groups.
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