January 8, 2019
Source: Idorsia LTD Press Release
Idorsia Ltd (SIX: IDIA) 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.
About the study
Cenerimod is being investigated in a multiple-dose study to evaluate its efficacy and safety for the treatment of adult patients with moderately to severely active, autoantibody-positive SLE. The multicenter, randomized, double-blind, placebo-controlled, parallel-group study will enroll around 500 patients, who will be randomized into four cenerimod treatment arms: 0.5, 1, 2, and 4mg once-daily orally or placebo for up to 12 months. Patients will receive study treatment in addition to background SLE therapy. The study aims to validate the appropriate dose, patient population and endpoints for further development in SLE.
Guy Braunstein, MD and Head of Global Clinical Development, commented:
“This study is based on a clinical pharmacology program in healthy volunteers and a Phase 2 safety study in patients with lupus, which showed that cenerimod reduced circulating lymphocytes in a dose-dependent manner and was safe and well tolerated at doses up to 4 mg. It has been designed to include input from health authorities. As background therapy may confound the treatment effect, the protocol recommends keeping SLE medications as stable as possible during the double-blind treatment period. The study also considers important patient perspectives, such as the overall quality of life and debilitating symptoms like fatigue.”