Date: 2015-07-29
Type of information: Initiation of the trial
phase: 2b
Announcement: initiation of the trial
Company: Arena Pharmaceuticals (USA - CA)
Product: APD334 - etrasimod
Action
mechanism: sphingosine 1-phosphate receptor (S1PR) modulator. Discovered by Arena, APD334 is an oral, investigational, Sphingosine 1-Phosphate Subtype 1 (S1P1) receptor modulator. S1P1 receptors have been demonstrated to be involved in the modulation of several biological responses, including lymphocyte trafficking from lymph nodes to the peripheral blood. By isolating subpopulations of lymphocytes in lymph nodes, fewer immune cells are available in the circulating blood to effect tissue damage.
Disease: ulcerative colitis
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: Canada, USA
Trial
details: The purpose of this study is to determine whether APD334 is a safe and effective treatment for ulcerative colitis.(NCT02447302)
Latest
news: * On July 29, 2015, Arena Pharmaceuticals announced the initiation of patient screening in a Phase 2 proof-of-concept clinical trial of APD334 in ulcerative colitis. This 12-week, three-arm, double-blind, placebo-controlled Phase 2 trial will enroll approximately 240 patients with moderate to severe ulcerative colitis. The primary endpoint of the trial is clinical remission. Continuation of treatment to 52 weeks will be offered to participants in a separate long-term extension study. Arena previously completed a Phase 1 program for APD334 that demonstrated a dose-dependent effect on lymphocyte count lowering in blood. A multiple-ascending dose, Phase 1 clinical trial showed mean decreases from baseline in lymphocyte counts up to 69% and recovery on average to baseline within one week of drug discontinuation. There was a modest impact on heart rate, but none of the changes were classified by the investigator as clinically significant. There were also no findings with respect to pulmonary function or liver enzyme tests that were classified by the investigator as clinically significant.
