San 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 directly caused by APD334. The researchers did not observe any serious adverse effects, nor did any participant have to discontinue taking the experimental drug.
“Lymphocyte lowering at the level demonstrated in this trial has been shown to correlate with clinical efficacy in Phase 2 and Phase 3 trials of other S1P1 modulators in multiple sclerosis, psoriasis and ulcerative colitis,” said Dr. William R. Shanahan, the Company’s Senior Vice President and Chief Medical Officer. “The results of this trial support investigation of the efficacy and safety of APD334 in patients with autoimmune diseases.”
“Based on these impressive results, we plan to expedite APD334 into Phase 2 clinical trials for ulcerative colitis and Crohn’s disease,” said Jack Lief, the Company’s President and Chief Executive Officer. “The advancement of this promising drug candidate further demonstrates Arena’s focused expertise in discovering and developing innovative drug candidates targeting G protein-coupled receptors that have the potential to improve health.”