Immunic leaps as vidofludimus shows promise in UC

US immunology focussed biotech Immunic Therapeutics (Nasdaq: IMUX) saw its shares soar more than 23% to $1.80 in early trading today, as it reported positive data from the maintenance phase of its Phase IIb CALDOSE-1 trial of its lead asset, vidofludimus calcium (IMU-838), in patients with moderate-to-severe ulcerative colitis (UC).

Data from the maintenance phase of CALDOSE-1 showed a dose-linear increase in clinical remission as compared to placebo at week 50. Moreover, an exploratory statistical analysis confirmed the 30mg dose of vidofludimus calcium to be statistically superior (p=0.0358) in achieving clinical remission at week 50, with a 33.7% absolute improvement over placebo.

Immunic noted that a similar effect on clinical remission rates at week 50 was also found among those patients who received corticosteroids during the induction phase. Finally, a dose-linear increase in endoscopic healing was observed, with the 30mg dose of vidofludimus calcium being associated with a 37.8% absolute improvement over placebo and also achieving statistical significance in an exploratory statistical analysis (p=0.0259).