Top-Line Results for Arena’s IBD Immunomodulator Announced

Top-Line Results for Arena’s IBD Immunomodulator Announced
IBDSan Diego, California-based Arena Pharmaceuticals, Inc. has just revealed positive findings from a Phase 1b clinical trial for APD334, an orally administered pipeline immunomodulator that works to lower destructive lymphocytes by targeting the sphingosine 1-phosphate subtype 1 (S1P1) receptor in order to treat autoimmune conditions, such as inflammatory bowel diseases (IBD). The randomized, double-blind, placebo-controlled Phase 1b clinical trial was designed to evaluate APD334's safety and tolerability profile, as well as understand the pharmacodynamics and pharmacokinetics of multiple-ascending doses of the drug. The study dosed and examined 50 healthy individuals, sorted into 5 distinct participant groups. Another 10 participants were placed in a control group and given a placebo for 21 days. This multiple ascending dose study revealed APD334's efficacy on modulating immune response to be dose-dependent, affecting an average reduction of up to 69 percent from baseline lymphocyte counts. Recovery of lymphocyte count to baseline levels took an average of one week from last dosing. While the researchers did not observe any untoward side effects with regard to cardiopulmonary function and liver enzyme levels, they noted several common adverse effects, such as, contact dermatitis, headache, and bowel alterations - none of which were determined to be
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