Germany-based clinical stage biotech company Immunic Therapeutics has received investigational new drug (IND) approval from the US Food and Drug Administration (FDA) to start a Phase ll trial of IMU-838 in patients with ulcerative colitis (UC).
The CALDOSE-1 trial is intended to help Immunic eventually demonstrate clinical efficacy of IMU-838 for the treatment of inflammatory bowel disease (IBD).
CALDOSE-1 aims to evaluate the efficacy of multiple doses of IMU-838 or placebo to induce symptomatic and endoscopic remission in patients with active UC.
It is expected to be conducted in the early part of this year across multiple sites in the US and Europe.
Immunic Therapeutics CEO Dr Daniel Vitt said: “This step underlines that we’re progressing well on our way to deliver a phase III ready product in due time.”
The company is also planning to start second Phase ll trial, CALDOSE-2, to treat patients with Crohn’s disease.
The proposed trial is expected to begin after receiving interim data from the new Phase ll trial of UC.
Immunic’s MU-838 is an orally available, next-generation selective immune modulator that targets intracellular metabolism of activated immune cells by inhibition of the enzyme ‘dihydroorotate dehydrogenase’ (DHODH).
IMU-838 was previously tested for pharmacokinetics (PK) and safety in two Phase ll studies.