Immunic, Inc. (NASDAQ:IMUX) is a clinical-stage biotechnology company focusing on developing orally administered, small-molecule therapies for chronic inflammatory and autoimmune diseases. The company is headquartered in New York City but conducts most of its research and development (R&D) activities at its subsidiary in Munich, Germany.
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In our last article, we saw a bird’s-eye view of Immunic and its pipeline of three small-molecule programs. Today, we will focus on its lead product candidate, Vidofludimus Calcium (IMU-838). The IMU-838 is targeting the treatment of multiple sclerosis (MS) and its various forms. To date, Vidofludimus Calcium has been tested on over 1,800 human subjects and patients, showing attractive and positive safety and tolerability profiles in both preclinical and clinical trials.
First, a Little About Multiple Sclerosis (MS)
MS is a neurodegenerative disorder in which an individual’s immune system attacks the outer protective layer of nerve cells, called myelin, present in the nervous system. This leads to damaged nerve cells, which ultimately results in the loss of signals from the brain to other parts of the body.
There are several forms of MS and Immunic is targeting each of them with IMU-838. The most common form is Relapsing MS (RMS), in which the patient undergoes repeated attacks of MS, with old or newer symptoms. When these symptoms begin to worsen over time, it is called Progressive MS (PMS).
Vidofludimus Calcium’s Advantages Over Other Drugs
Immunic aims to create high-quality, oral medications that display therapeutic efficacy and superior safety and tolerability for patients with MS. The company believes in Vidofludimus Calcium’s combined power of neuroprotective, anti-inflammatory, and anti-viral properties, promising to address multiple drivers of neurodegeneration in patients suffering from MS. These three combined properties highlight IMU-838’s advantages compared to several existing medications for treating MS, including injectables and oral drugs.
The drug works by selectively inhibiting dihydroorotate dehydrogenase (DHODH), an enzyme required for the multiplication/production of activated T-cells and B-cells. Vidofludimus Calcium is expected to reduce the function of only the activated cells, leaving the non-active cells unaffected. This helps the immune system to continue to fight the disease.
Vidofludimus Calcium has the ability to activate the neuroprotective transcription factor nuclear receptor-related 1, (or Nurr1), which reduces pro-inflammatory cytokines and blocks the production of neurotoxic agents like reactive oxygen species and nitric oxide.
Moreover, the drug’s anti-inflammatory properties help selectively target hyperactive immune cells, thus reducing the probability of relapses as well as brain atrophy (loss of brain cells).
Furthermore, its anti-viral effects have the potential to restrain the Epstein-Barr virus-related T-cells linked to MS. Multiple studies have shown that MS is triggered by infection from Epstein-Barr virus (EBV).
According to the company’s data, testing of Vidofludimus Calcium has shown therapeutic activity in Phase 2 clinical trials for relapsing-remitting multiple sclerosis (EMPhASIS trial), interim analysis of the CALLIPER trial for PMS, as well as for moderate-to-severe ulcerative colitis (CALDOSE-1 trial). Meanwhile, the Phase 3 clinical trial for RMS (ENSURE program) is underway.
Interestingly, in March 2024, Immunic received the fourth U.S. patent from the United States Patent and Trademark Office (USPTO) for the composition-of-matter of a specific polymorph of Vidofludimus Calcium. The patents granted so far protect the drug until 2041 in the U.S. and 2039 in international markets.
What is the Price Target for Immunic Stock?
On TipRanks, the average Immunic price target is $14.33, which implies a massive 1191% upside potential, a sign of solid expected recovery from the current levels. Also, IMUX stock has a Moderate Buy consensus rating based on two Buys and one Hold recommendation. Year-to-date, IMUX stock has lost 26% of its value.
This article was written in partnership with Immunic. TipRanks may be compensated for its publication.
