Teva Pharmaceutical Industries and Active Biotech have announced positive data from a Phase IIa laquinimod trial in active Crohn’s disease (CD).
The data demonstrated that the oral administration of laquinimod at 0.5mg/day led to a steady, positive 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 programme 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.
The multicentre, randomised study tracked four dose cohorts who received laquinimod at 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, or placebo for eight weeks, with four weeks follow-up.
Higher doses did not exhibit any effect on remission or response, while laquinimod 0.5mg and 1mg doses were well-tolerated, exhibiting adverse events comparable to placebo.
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The company is analysing the data to determine further steps in the CD clinical development plan.
The study allowed stable concomitant therapies and previous anti-tumour necrosis factor usage among patients.
Image: Teva Phase IIa study evaluated the safety and efficacy of various doses of laquinimod in Crohn’s disease patients. Photo: Courtesy of ????.