Immunic Inc (NASDAQ:IMUX) has announced positive data from the maintenance phase of its phase 2b CALDOSE-1 trial of lead asset vidofludimus calcium (IMU-838) in patients with moderate-to-severe ulcerative colitis (UC).
The company said data from the maintenance phase of CALDOSE-1 showed a dose-linear increase in clinical remission as compared to the 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.
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Maintenance phase highlights include:
- 50-week maintenance phase data shows dose-linear increase in clinical remission for vidofludimus calcium as compared to placebo; and
- 30 mg once-daily dose of vidofludimus calcium demonstrated statistically significant rates of clinical remission (p=0.0358) and endoscopic healing (p=0.0259) at week 50.
"These impressive results from the maintenance phase of our CALDOSE-1 trial in patients with UC are extremely encouraging as they demonstrate statistically significant activity of vidofludimus calcium as compared to placebo,” Immunic CEO and president Dr Daniel Vitt said in a statement. “We believe this data compares favorably to available maintenance data for other UC drugs.”
"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,” he added.
The company said it 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, it noted that 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. As a result, it said 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, it said the previous phase 2a ENTRANCE study had already shown that vidofludimus has a high response rate in replacing steroids among steroid-dependent UC patients.
Safe and well-tolerated
Consistent with prior data sets in other patient populations, the company said the 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, it added.
"Results from the maintenance phase of our CALDOSE-1 trial confirm previous observations in the induction phase that vidofludimus calcium provides a benefit regarding clinical remission, as compared to placebo, in UC patients not using concomitant corticosteroids," said Dr Andreas Muehler, chief medical officer of Immunic.
"Chronic corticosteroid administration is undesirable in clinical practice due to medically important adverse effects that are well documented. Therefore, future clinical trials of vidofludimus calcium could easily be performed without concomitant steroid use. We are also pleased to see that, once again, the study data confirms the very favorable safety and tolerability profile of vidofludimus calcium observed in other trials,” he added.
Immunic noted that 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.
Update on Izumerogant (IMU-935) and IMU-856 development programs
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 said it 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 noted 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.
The company said it will host a webcast today, April 5 2022, at 8.00am ET.
To participate in the webcast, register in advance here or on the 'Events and Presentations' section of Immunic's website. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial-in access.
An archived replay of the webcast will be available approximately one hour after completion on Immunic's website.
Immunic is a biotechnology company developing a clinical pipeline of orally administered, small-molecule therapies for chronic inflammatory and autoimmune diseases.
The company's lead development program, vidofludimus calcium (IMU-838), currently in phase 3 clinical trials for the treatment of multiple sclerosis, selectively inhibits activated immune cells and shows combined anti-inflammatory, anti-viral and neuroprotective effects.
IMU-856 is targeted to restore intestinal barrier function and regenerate bowel epithelium, which would be applicable in numerous gastrointestinal diseases, such as celiac disease, where it is currently being evaluated in a clinical proof-of-concept trial.
Contact the author at stephen.gunnion@proactiveinvestors.com