Monday, June 24, 2019

Immunic has previously unpublished data on IBD treatment candidate

Immunic, Inc. (IMUX), a clinical-stage biopharmaceutical company focused on developing potentially best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, announced that Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present today previously unpublished data regarding the company’s lead program, IMU-838, at the GI Inflammatory Diseases Summit (GIIDS) in Boston. The presentation, entitled, “IMU-838 in Clinical Phase 2 – New Selective Oral Treatment for IBD,” will take place at 3:30 pm ET. IMU-838, currently in phase 2 clinical development for the treatment of ulcerative colitis (UC) and relapsing-remitting multiple sclerosis (RRMS), is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH).
Highlights of Dr. Kohlhof’s presentation will include these newly released findings:
  • Preclinical data shows that IMU-838 appears selective towards those T cells producing high amounts of the pro-inflammatory cytokines, IFNγ and IL-17.
  • In mixed lymphocyte reaction assays in combination with the anti-TNFa antibody infliximab, IMU-838 was shown to act synergistically with regard to the induction of regulatory macrophages, important for the efficacy of such anti-TNFa antibodies.
  • In addition to previous inflammatory bowel disease animal models, IMU-838 also demonstrated activity in a therapeutic animal colitis model with improvement of diarrhea score and significant TNFa reduction in the gut.
Dr. Kohlhof’s presentation will also highlight the following advantages of IMU-838:
  • As a DHODH intrinsic effect, IMU-838 is, in-vitro, able to inhibit reactivation of several viruses. Other immunosuppressive drugs used for the treatment of inflammatory bowel disease and multiple sclerosis are known to have virus reactivation as one of the clinically significant adverse drug effects.
  • In comparison to other DHODH inhibitors, IMU-838 does not target any kinases and does not exhibit an increased rate of side effects, such as diarrhea, alopecia, or neutropenia. Notably, these attributes do not seem to be a class effect of DHODH inhibitors. No signal for an increased rate of liver enzyme elevation has been seen, to date, in the clinical trials. With a terminal half-life of 30 hours in blood plasma, IMU-838 is well suited for convenient, once daily oral dosing, reaching steady state exposure after 5-7 days of treatment and washing out within 10-14 days in most patients.
  • In a phase 2a clinical study in steroid dependent UC and Crohn’s disease patients, the active moiety of IMU-838 (vidofludimus) has shown activity in the ability to wean off steroids, with a total response rate of 88.5%.

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