Immunic punts psoriasis, prostate cancer programs to narrow focus onto multiple sclerosis, celiac disease

Immunic can no longer keep all its balls in the air. Rather than keep advancing on three fronts, the firm has decided to deprioritize development in psoriasis and castration-resistant prostate cancer and throw its remaining resources at two other programs.

The New York-based biotech has three clinical-phase candidates: IMU-838, IMU-935 and IMU-856. With a pair of phase 3 studies of IMU-838 in multiple sclerosis chipping away at its bank balance, Immunic is pulling back from another of the assets. IMU-935, also known as izumerogant, is the candidate that the biotech is sacrificing in the wake of clinical data that disappointed investors. 

Immunic based the decision to deprioritize development of IMU-935 in psoriasis and castration-resistant prostate cancer on changes in the expected time to market, “increased complexity of potential further development in this competitive field” and the expected impact on R&D costs. The biotech will explore whether a backup molecule to IMU-935, an inverse agonist of RORγ, is worth advancing instead. 

Deprioritizing clinical development of IMU-935 will free Immunic to use its remaining funds, which stood at $116.4 million at the end of last year, to advance IMU-838 and IMU-856. The biotech expects to share initial phase 1b trial data on IMU-856 in celiac disease later this quarter and report on an interim analysis of a phase 2b study of IMU-838 in progressive multiple sclerosis in the second half of the year. 

Top-line data on the phase 2b trial of IMU-838, an inhibitor of dihydroorotate dehydrogenase, are due to be released around the end of next year. By then, Immunic aims to have interim data from the IMU-838 phase 3 program in relapsing multiple sclerosis, too. 

Whether it will have any money is another question. Having closed a $60 million private placement in October, the biotech expects its cash runway to last into the fourth quarter of next year. Full data from the pair of phase 3 multiple sclerosis studies are due at the end of 2025.

Immunic disclosed the pipeline prioritization plans alongside phase 2b results for IMU-838 in ulcerative colitis. In June, the biotech revealed that the study had missed its primary endpoint, a setback it blamed on “unexpected interference” between the drug candidate and concurrent use of corticosteroids. The failure prompted Immunic to abandon plans to advance IMU-838 in the indication without a partner.

The biotech continued with the maintenance phase of the ulcerative colitis study, leading to the data it published today. While the impact of corticosteroids got the blame for the induction phase flop, it is now being reframed as a feature, not a bug, with Immunic hailing the efficacy in patients who took IMU-838 without the side effect-causing steroids.