The first patient has enrolled in the CALDOSE-1 phase 2 clinical trial, which seeks to determine whether Immunic AG‘s investigational drug IMU-838 can induce and maintain remission in patients with active ulcerative colitis (UC).

The first sites for the trial are in the United States, and recruitment of participants is already underway across multiple U.S. sites.

The primary goal of the CALDOSE-1 trial (NCT03341962) is to demonstrate the clinical efficacy of multiple doses of IMU-838 or placebo to induce remission in patients with active UC. The trial will also seek to determine the ability of IMU-838 to maintain remission. Ulcerative colitis is one of the two most common forms of inflammatory bowel disease (IBD), along with Crohn’s disease.

In Europe, several regulatory agencies have granted approvals for CALDOSE-1 and approximately 200 patients are expected to be enrolled in more than 80 sites across 10 countries in this global clinical trial.

“After preparing this trial for many months in collaboration with international experts, we are very excited that the trial has now entered its enrollment phase,” Dr. Andreas Muehler, Chief Medical Officer of Immunic, said in a press release. “Demonstration of clinical efficacy and confirmation of the most appropriate dose brings IMU-838 a step closer to be available for patients with active ulcerative colitis in the future, something that the Immunic team hopes will potentially give these patients better therapeutic options for oral therapies that are more compatible with their daily life and work activities.”

Dr. Daniel Vitt, CEO of Immunic adds, “The commencement of this large international trial is the important first step in a series of planned Phase 2 studies with the goal to position IMU-838 as the best oral choice for treatment of IBD and other chronic inflammatory and autoimmune diseases. Achieving clinical proof of concept of IMU-838 in patients with ulcerative colitis is one of the major near-term goals for Immunic.”

Approval by the U.S. Food and Drug Administration of an investigational New Drug (IND) application in January 2018 paved the way for the biotech company to initiate the clinical trial.

The first data from CALDOSE-1 will come from an interim analysis after approximately 60 patients have concluded the induction phase of the trial. In addition, Immunic is preparing a second Phase 2 trial (CALDOSE-2) in patients with Crohn’s disease.