Immunic, Inc. (IMUX) is a clinical-stage biotechnology company that is focused on researching and developing small-molecule, oral medicines for treating chronic inflammatory and autoimmune diseases. The company is headquartered in New York, with most research operations conducted in Munich, Germany.
So far, we have seen how Immunic is disrupting the unmet needs of patients suffering from multiple sclerosis (MS) and its subtypes, namely Relapsing MS (RMS) and Progressive MS (PMS). In this article, we will look at another chronic autoimmune disorder, celiac disease, for which Immunic is striving to find a cure through its IMU-856 program, as there is no proven drug or treatment to date.
Immunic’s Focus on Celiac Disease
Celiac disease is an autoimmune disease that attacks the small intestine. People suffering from celiac disease are gluten intolerant. Consumption of gluten in patients suffering from celiac disease damages the lining of the small intestine.
Immunic sees a grave need for a cure for celiac disease, as studies show that 1 in every 100 people is suffering from this disease globally. In the U.S. alone, approximately two million people have been diagnosed with celiac disease, while another one million remain undiagnosed.
It is worth noting that gluten intolerance may not be the only reason for celiac disease. Certain studies are still underway to diagnose how and what triggers the autoimmune reaction in the small intestine, such as the existence of some genes.
Scope and Current Status of the IMU-856 Program
IMU-856 is a small-molecule, oral epigenetic regulator that helps restore intestinal barrier function and regenerate bowel epithelium. The drug targets Sirtuin 6, or SIRT6, a protein responsible for the above two functions.
Importantly, in pre-clinical trials, IMU-856 has shown that it can avoid the suppression of immune cells and may have the potential to maintain immune surveillance for patients during therapy. This reflects a major advantage compared to chronic treatments involving potentially immunosuppressive medications.
In the Phase 1/1b clinical trial of IMU-856, Immunic conducted a three-part, double-blind, randomized, placebo-controlled test. Parts A and B involved healthy individuals/volunteers, while Part C included patients with celiac disease during periods of gluten-free diet and gluten challenge. IMU-856 showed the following four positive effects as compared to placebo: protection of the gut wall, symptomatic improvement related to gluten exposure, biomarker response, and increased nutrient absorption in terms of Vitamin B12, iron, and zinc-related measures.
Overall, IMU-856 has shown considerable safety and tolerability in the trials so far. IMU-856 is being investigated as a potential drug that helps restore a healthy gut without targeting the immune system. Moreover, it is being tested as a potential treatment for other gastrointestinal disorders such as ulcerative colitis, Crohn’s disease, or irritable bowel syndrome with diarrhea.
It is important to note that Immunic has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) covering the composition-of-matter of IMU-856 and related pharmaceutical compositions. This provides it protection until at least 2038.
Immunic is currently gearing up for Phase 2 testing of IMU-856 in patients with ongoing active celiac disease (OACD), despite a gluten-free diet.
What is the Price Target for Immunic?
On TipRanks, IMUX stock has a Moderate Buy consensus rating based on one Buy and one Hold recommendation. The average Immunic price target of $16.50 implies 1179.1% upside potential from current levels. Year-to-date, IMUX shares have declined 14%.
This article was written in partnership with Immunic. TipRanks may be compensated for its publication.
