Immunic with Phase II setback in ulcerative colitis

07 Jun 2022

Immunic with Phase II setback in ulcerative colitis

Immunic Inc has announced that vidofludimus calcium did not induce clinical remission in patients with moderate-to-severe ulcerative colitis (UC) during a Phase II trial called CALDOSE-1, missing the study's primary objective. No significant differences were observed between the three active dose groups or on any of the secondary measures, including symptomatic remission and endoscopic cure, Immunic reported.

The company, which is based in Gräfelfing near Munich, Germany, and the US, blamed unexpected interference between vidofludimus calcium and concomitant use of corticosteroids commonly prescribed to treat UC for the failure. "We are disappointed with the results of the CALDOSE-1 trial. The interference of vidofludimus calcium with concurrent corticosteroid use is surprising, and we will further explore the mechanism behind this unexpected observation," said Chief Medical Officer Andreas Muehler.

Even with further fine-tuning of the clinical trial data, it cannot be ignored that the remission rate was higher in the placebo group than in the treated group, regardless of whether steroids were taken or not. Consequently, Immunic will now discontinue the development line in UC. Shares of Immunic fell on the news from around US$5.95 on Wednesday to around US$3.40 on Friday afternoon. The company reported cash of US$93.1 million as of 31 May, which is expected to fund operations through the fourth quarter of 2023.

Vidofludimus calcium will be continued in the indication multiple sclerosis, where it had previously shown a treatment effect during a phase II trial. Several studies are ongoing in this indication and CEO Daniel Vitt remains hopeful: " We will use this opportunity to focus our vidofludimus calcium-related efforts around the ongoing multiple sclerosis program, including the phase 3 trials in relapsing multiple sclerosis (RMS) and the phase 2 trial in progressive multiple sclerosis (PMS). As evidenced by data from our phase 2 EMPhASIS trial, we believe vidofludimus calcium holds the potential for meaningful differentiation based on anticipated strong efficacy, unprecedented safety and tolerability, oral delivery, and neuroprotective effects. Also with other drug candidates the company is well positioned: "We also 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.”

However, the remaining hopes for vidofludimus now lie solely in the multiple sclerosis clinical trial. Other assets in Immunic's pipeline include IMU-935 for psoriasis and IMU-856 for celiac disease.