The first healthy volunteer has been dosed in an Australian Phase 1 clinical trial investigating IMU-856, a potential novel treatment for inflammatory bowel disease (IBD), according to the therapy’s developer Immunic Therapeutics.
IBD is an autoimmune disorder in which cells of the immune system attack the digestive tract, causing inflammation that leads to gastrointestinal symptoms. Typically, IBD treatments are targeted at reducing inflammation, but this can lower immune system activity, potentially leaving a patient vulnerable to other complications.
Instead of targeting inflammation, IMU-856 was designed to restore the functionality of the intestinal barrier, the dysfunction of which is implicated in a number of digestive conditions, including IBD. Of note, disruption of the intestinal barrier can cause microbes and other foreign compounds to pass into the intestine, triggering an immune response and causing inflammation.
“Current treatments for many gastrointestinal conditions focus on inhibiting inflammation and do not directly address impaired intestinal barrier function,” Hella Kohlhof, PhD, chief scientific officer of Immunic, said in a press release.
“In contrast, IMU-856 appears to have a unique targeted ability to strengthen and thereby normalize this function, potentially avoiding the bacterial triggers which can occur when the intestinal barrier is impaired,” she said.
IMU-856 is a small oral molecule that targets an as-of-yet undisclosed protein involved in the regulation of intestinal barrier function.
Preclinical data from Immunic showed that the treatment improves the intestinal barrier function and with little to no effect on the immune system, prompting the Bellberry Human Research Ethics Committee in Australia to approve a Phase 1 trial.
Immunic’s double-blind, randomized, placebo-controlled Phase 1 trial testing IMU-856 will occur in three parts.
The first part will test a single ascending dose in healthy volunteers, meaning that each volunteer will be given only one dose of IMU-856, and that the dosage level will increase with subsequent volunteers.
The second part is a multiple ascending dose phase, in which healthy volunteers will take IMU-856 once a day for 14 consecutive days, with increasing dosage levels for subsequent volunteers.
The first two parts are intended to establish IMU-856’s safety, tolerability, and pharmacokinetics (how a medication moves in the body) in healthy volunteers.
The third part will investigate IMU-856 in patients with diarrhea-predominant irritable bowel syndrome, ulcerative colitis, and Crohn’s disease who have a high degree of intestinal barrier dysfunction.
In this part, patients will be given IMU-856 once daily for 28 days and monitored for changes in intestinal barrier integrity. The study will include two dosage groups and a placebo group for comparison.
“Based on strong preclinical data, IMU-856 shows significant therapeutic potential for diseases that are known to be triggered by the disruption of intestinal barrier function,” said Daniel Vitt, PhD, CEO and president of Immunic.
Immunic obtained the global license for IMU-856, which was originally developed by Daiichi Sankyo, in November 2018, granting it exclusive rights to potentially commercialize IMU-856 worldwide.