According to the study data, the oral administration of laquinimod 0.5mg/day exhibitted the steady effect on remission and response rates in patients with moderate-to-severe CD versus placebo.
Teva Pharmaceutical Industries global R&D president and chief scientific officer Dr. Michael Hayden said, "Our developmental program for laquinimod has demonstrated that the immunomodulatory effects of this oral compound stand to apply to multiple autoimmune diseases, and data presented at UEG showed an impressive impact on clinical remission in Crohn’s disease as early as one week of treatment."
The double-blind, placebo-controlled trial enrolled approximately 45 patients in a 2:1 ratio between laquinimod and placebo in each of the four cohorts of variying doses.
The study observed four dose cohorts who received laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, or placebo for eight weeks with four weeks follow-up and evaluated the safety and efficacy.
Higher doses did not exhibit any effect on remission/response while laquinimod 0.5mg and 1mg doses were well-tolerated, exhibiting adverse events comparable to placebo.