Immunic reports CALDOSE-1 trial data, to deprioritize izumerogant development

Immunic reported data from the maintenance phase of its phase 2b CALDOSE-1 trial of lead asset, vidofludimus calcium, or IMU-838, in patients with moderate-to-severe ulcerative colitis, or UC. The maintenance phase efficacy data at week 50 are as follows: As shown above, 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 30 mg dose of vidofludimus calcium to be statistically superior in achieving clinical remission at week 50, with a 33.7% absolute improvement over placebo. 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 30 mg dose of vidofludimus calcium being associated with a 37.8% absolute improvement over placebo and also achieving statistical significance in an exploratory statistical analysis. Immunic believes that the maintenance phase data of CALDOSE-1 confirms vidofludimus calcium’s impressive activity in the absence of chronic corticosteroid co-administration. Data from the induction phase, released in June of 2022, showed clinical remission rates of 14.7% for the pooled vidofludimus calcium arms and 3.3% for the placebo arm among those patients not being treated concurrently with chronic corticosteroids. At the same time, this benefit was not seen among the population to whom corticosteroids were chronically co-administered. During the maintenance phase, all corticosteroids were required to be tapered, if possible. Hence, the maintenance phase results are in line with the induction data without chronic concomitant use of corticosteroids and underline the performance of vidofludimus calcium in this steroid-free UC population. On a related note, the previous phase 2a ENTRANCE study had already shown that vidofludimus has a high response rate in replacing steroids among steroid-dependent UC patients.Consistent with prior data sets in other patient populations, administration of vidofludimus calcium in the maintenance phase of this trial was observed to be safe and well-tolerated. No new safety signals were observed. The incidence of treatment-emergent adverse events in both the 10 mg and 30 mg dose groups of vidofludimus calcium was comparable with placebo. There were no increased rates of liver events, liver enzyme elevations, renal events or adverse events of special interest, when compared to placebo, and no Hy’s Law cases were observed. The CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe UC was a phase 2b, multicenter, randomized, double-blind, placebo-controlled, dose-finding study, including a blinded 10-week induction phase and a blinded 50-week maintenance phase. In the induction phase, 263 UC patients were enrolled at 78 study sites in the United States and Western, Central and Eastern Europe, and patients were randomized into three active dosing arms of 10 mg, 30 mg, 45 mg once-daily, as well as placebo. The primary endpoint comprised a composite of a patient-reported outcome and endoscopy-assessed outcome, also referred to as clinical remission, both evaluated following ten weeks of induction treatment. During the maintenance phase, 112 patients were re-randomized to receive 10 mg or 30 mg once-daily doses of vidofludimus calcium, while placebo patients who achieved symptomatic revision were "sham randomized" to continue receiving placebo in the maintenance phase. In order to focus on the rapidly advancing vidofludimus calcium and IMU-856 programs, and considering the positive results from the CALDOSE-1 trial of vidofludimus calcium in UC, as well as the totality of available data for izumerogant, including changes in expected time to market and increased complexity of potential further development in this competitive field, Immunic has decided to focus its resources and, therefore, deprioritize the clinical portion of its izumerogant development program in psoriasis and castration-resistant prostate cancer. Regarding IMU-856, the company notes that the part C portion of the ongoing phase 1 clinical trial in celiac disease patients has been proceeding more quickly than anticipated, with initial data expected to become available in the current quarter.