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Immunic : Phase 2 Trial Of Vidofludimus Calcium On Ulcerative Colitis Fails To Meet Primary Goal

Immunic Inc. (IMUX) said Thursday that phase 2 CALDOSE-1 trial of vidofludimus calcium did not achieve primary endpoint in patients with moderate-to-severe ulcerative colitis, due to unexpected interference between vidofludimus calcium and concurrent use of corticosteroids.

In Thursday pre-Market trade, IMUX was trading at $2.01, down $3.89 or 65.93%.

In ulcerative colitis population without concurrent steroid use, pooled vidofludimus calcium data suggested activity in clinical remission over placebo; counterbalanced by interference observed in the ulcerative colitis population with concurrent steroid use.

The company noted that it does not plan further development activities in ulcerative colitis without a partner. It will focus on ongoing phase 3 development of vidofludimus calcium in multiple sclerosis, and ongoing IMU-935 and IMU-856 programs.

The company said it eagerly await further clinical data for IMU-935 and IMU-856 later this year, including phase 1b data of IMU-935 in moderate-to-severe psoriasis patients in the second half, and phase 1 safety data of IMU-856 in healthy human subjects in the third quarter. Both of these investigational medicines hold tremendous potential in their intended indications and beyond.

Cash and cash equivalents as of May 31, 2022 were $93.1 million. The company expects to have funding into the fourth quarter of 2023.

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