Immunic surges ~20% as IMU-838 shows promise in ulcerative colitis trial

Immunic (NASDAQ:IMUX) reported 50-week data from a maintenance phase of a phase 2b trial of vidofludimus calcium (IMU-838) to treat patients with moderate-to-severe ulcerative colitis (UC) and noted that it would deprioritize izumerogant (IMU-935) program.

The company said data from the phase 2b trial, dubbed CALDOSE-1, showed that clinical remission rate (CRR) was seen in 42.3% (N=11/26) of patients receiving IMU-838 10-mg dose; 61.5% (N=16/26) on the 30-mg dose, and 27.8% (N=5/18) of those on placebo.

Steroid-free clinical remission rate was reported in 38.5% (N=10/26) of patients on the 10-mg dose; 61.5% (N=16/26) of those on the 30-mg dose, and 27.8% (N=5/18) of those on placebo.

In addition, a similar effect on clinical remission rates at week 50 was also seen among those patients who received corticosteroids during the induction phase, according to the company.

Immunic noted that a dose-linear increase in endoscopic healing was seen, with the 30-mg dose being linked with a 37.8% absolute improvement over placebo.

Vidofludimus calcium was safe and well-tolerated and no new safety signals were seen, according to the company.

"Although we do not intend to initiate phase 3 development of vidofludimus calcium in UC on our own and without additional funding and resource allocation, based on this encouraging outcome, we will explore an exciting variety of options for the UC program as well as other inflammatory bowel disease (IBD) indications," said Immunic and CEO Daniel Vitt.

In addition, Immunic said it has decided to focus its resources and deprioritize the clinical portion of its izumerogant development program in psoriasis and castration-resistant prostate cancer.

The company noted that the decision was made to focus on vidofludimus calcium and IMU-856 programs, considering positive results from the CALDOSE-1, and the available data for izumerogant, including changes in expected time to market and complexity of potential further development in this competitive field.

For IMU-856, the company said that the part C portion of an ongoing phase 1 study in celiac disease was proceeding more quickly than expected, with initial data anticipated in the current quarter.

UC is an inflammatory bowel disease which causes inflammation and ulcers in the digestive tract.

IMUX +19.18% to $1.74 premarket April 5