February 10, 2016 – InDex Pharmaceuticals AB today announced that the World Health Organization (WHO) has recommended cobitolimod as the International Nonproprietary Name (INN) for Index´s lead drug candidate Kappaproct®, which is a first-in-class Toll-like receptor (TLR) 9 agonist in late-stage clinical development for moderate to severe ulcerative colitis.
The aim of the INN system is to provide a unique and universally designated name for each pharmaceutical substance to facilitate the identification of active pharmaceutical ingredients. A nonproprietary name is also known as a generic name. The name cobitolimod has been selected and passed the review of the Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. Following public consultation over four months, it has reached the status of recommended INN and will be included in the forthcoming list of recommended INN published by the WHO.
“We are very pleased that the WHO recognizes the unique nature of Kappaproct by accepting the proposed generic name cobitolimod,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “We will now introduce the use of cobitolimod in our communication with the scientific medical community. This is a very important step towards bringing a new drug to market and comes at an important time for InDex as we are preparing for our next clinical study with cobitolimod in moderate to severe ulcerative colitis to be initiated later this year.”
Kappaproct (cobitolimod) is InDex Pharmaceutical’s lead drug candidate in late-stage clinical development for moderate to severe ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Kappaproct provides local anti-inflammatory effects, leading to healing of the colonic mucosa and improvement of clinical symptoms.
Kappaproct 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. Kappaproct has achieved clinical proof-of-concept in moderate to severe ulcerative colitis, with a very favorable safety profile. Data from four placebo controlled clinical trials show that Kappaproct has statistically significant effects on those endpoints that are most relevant both from a regulatory and clinical perspective, such as key clinical symptoms, i.e. blood in stool, number of stools, and mucosal healing.
Contact InDex Pharmaceuticals:
Peter Zerhouni, CEO
Tel: +46 8 508 847 35