InDex Pharmaceuticals develops DIMS, DNA based immunomodulatory sequences, for potential use in treatment of various immunological diseases. The lead drug candidate cobitolimod (Kappaproct®, DIMS0150) is in late stage clinical development for moderate to severe ulcerative colitis (UC).
InDex Pharmaceuticals was founded in the year 2000 and is based at the Karolinska Institutet Science Park in Stockholm. Among the main owners are SEB Venture Capital, Industrifonden and NeoMed Management.
A technology platform based on the 2011 Nobel Prize
Toll-like receptors (TLR) lie at the core of InDex Pharmaceutical’s research and clinical development. By using a proprietary technology platform, the company has been able to design TLR9 agonists with the potential to be used for treatment of various immunological diseases.
Ulcerative Colitis is a chronic and disabling disease
Ulcerative colitis is a chronic inflammatory bowel disease of unknown cause and with no cure. Symptoms include abdominal pain, diarrhea, blood in stool, fever, weight loss and anemia. Today, patients are usually treated with anti-inflammatory, immunosuppressive and biological drugs.
Cobitolimod – a first in class treatment
InDex Pharmaceuticals aims to bring new hope to treatment refractory UC patients by developing cobitolimod – a first-in-class treatment with potential to alleviate symptoms together with having an excellent safety profile. Cobitolimod provides a local anti-inflammatory effect, leading to healing of the colonic mucosa and improvement of clinical symptoms. Cobitolimod is a single-stranded, DNA-based synthetic oligonucleotide that functions as an immunomodulatory agent by targeting TLR9 and thereby mimics microbial DNA being the natural ligand of the receptor.
Cobitolimod has a very low systemic absorption. This gives the drug a favorable safety profile, in sharp contrast to most other treatments under development as well as the marketed drugs. In addition, cobitolimod is one out of few drug candidates in pipeline with a new mechanism of action. InDex has clinical supportive data on cobitolimod from several placebo controlled clinical trials showing that cobitolimod has statistically significant effects on key endpoints such as blood in stool, number of stools, and mucosal healing. These are the endpoints that regulatory agencies as well as key opinion leaders consider the most important for the disease.
InDex has also developed DiBiCol, which is a diagnostic test that differentiates between UC and Crohn’s disease, the two major forms of inflammatory bowel disease (IBD). At the same time the test either confirms IBD, or points to other non-IBD conditions like the less severe condition Irritable Bowel Syndrome (IBS).
DiBiCol received market approval in Sweden in 2009 and as of June 2012 the DiBiCol Sampling Kit is CE marked.