FDA approves IND for Immunic Therapeutics' IMU-838 to Proceed with Phase 2 Study in Ulcerative Colitis
January 11, 2018 at 12:00 pm IST
Share
Immunic AG announced that it has received communication from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for its oral investigational drug IMU-838. This will allow Immunic to initiate the Phase 2 trial in patients with ulcerative colitis (UC). This IND approval marks a significant milestone for Immunic. This clinical trial (CALDOSE-1), is the first Phase 2 trial as part of the global development plan with the goal to demonstrate clinical efficacy of IMU-838 for inflammatory bowel disease (IBD). The company is pleased receiving the swift IND approval from the FDA. This will accelerate company’s development of IMU-838 as a promising candidate for therapies of chronic inflammatory bowel diseases. The FDA's approval of IND application is a big milestone in developing selective immune modulator IMU-838 into a globally available drug for the treatment of IBD. The US IND enables Immunic to initiate the first Phase 2 trial of IMU-838 (CALDOSE-1) which will investigate the efficacy of multiple doses of IMU-838 or placebo to induce symptomatic and endoscopic remission in patients with active UC. The study is planned to start soon and will be carried out in the US and Europe. In addition, Immunic is preparing a second Phase 2 trial (CALDOSE-2), in patients with Crohn's disease which is planned to commence after receiving interim data from the UC trial.
Immunic, Inc. is a biotechnology company. The Company is focused on developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The Companyâs s lead development program, vidofludimus calcium (IMU-838), is in phase III and phase II clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase II clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis, and moderate-to-severe ulcerative colitis. IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease. IMU-381 is in preclinical testing, a next generation molecule being developed to specifically address the needs of gastrointestinal diseases.