Stockholm, March 20, 2012 – InDex Pharmaceuticals today announced the development of a companion diagnostic test for Kappaproct. Kappaproct, the lead product candidate of InDex, is currently in a phase III study as a treatment for chronic active, treatment refractory ulcerative colitis. In this study, the companion diagnostic test is being evaluated to demonstrate a correlation between test result and clinical response to Kappaproct.
In previous clinical trials, Kappaproct has shown positive effects for the treatment of steroid resistant ulcerative colitis patients. The companion diagnostic test aims to enable the pre-selection of steroid resistant patients that are most likely to benefit from Kappaproct. The proprietary in vitro test is based on a number of biomarkers and is performed on a blood sample prior to administration of Kappaproct.
A companion diagnostic is designed to assess whether a patient will respond favorably to a specific medical treatment or not. Companion diagnostics are a crucial element of personalized medicine, which is becoming increasingly important along with the demand for safer and more efficacious medicines. Companion diagnostics also reduce healthcare costs as the use of ineffective therapies can be avoided.
“InDex Pharmaceuticals is dedicated to personalized medicine. The development of our companion diagnostic test will ensure that the patients treated with Kappaproct are most likely to respond to the drug. Treating only those individuals who are likely to benefit, will increase patient safety, improve outcomes and lower healthcare costs,” said Jesper Wiklund, CEO of InDex Pharmaceuticals.
In 2009, InDex Pharmaceuticals launched the diagnostic test DiBiCol in Sweden. DiBiCol differentiates between ulcerative colitis (UC) and Crohn’s disease (CD), the two major forms of inflammatory bowel disease (IBD).
About Ulcerative Colitis
Ulcerative colitis is a chronic, relapsing-remitting disease caused by inflammation of the colon. Although current UC treatments are effective for many patients with mild to moderate disease, a significant unmet medical need exists for patients with severe UC. Many of these severe cases have failed all available pharmaceutical therapies. For those patients, surgical removal of the colon by partial or complete colectomy is currently the only remaining treatment option.
Kappaproct is a single-strand, DNA-based synthetic oligonucleotide. It functions as an immuno- modulatory agent by targeting the toll-like receptor (TLR9). In a Phase II trial, Kappaproct has shown positive effects in the treatment of steroid resistant ulcerative colitis patients. In a compassionate use program, Kappaproct was able to induce clinical remission at week 12 in 10 out of 14 (71%) treatment refractory ulcerative colitis patients that had been elected for colectomy. A European multicenter Phase III study, COLLECT, is currently being conducted to evaluate the efficacy and safety of Kappaproct for the treatment of chronic active ulcerative colitis patients not responding to available therapy. More information about the ongoing study can be found on clintrials.gov with the ClinicalTrials.gov Identifier NCT01493960. Kappaproct has received orphan drug designation in Europe.
About InDex Pharmaceuticals
InDex Pharmaceuticals is a biopharmaceutical company focusing on the discovery and development of immunology-based treatments exclusively addressing disease states with a high unmet medical need. InDex Pharmaceuticals is also dedicated to personalized medicine and is developing companion diagnostics that will allow for the selection of only those patients likely to respond to a treatment. InDex Pharmaceuticals was founded in 2000 and is located in Stockholm, Sweden.
For additional information about companion diagnostics, COLLECT, Kappaproct and InDex Pharmaceuticals please visit www.indexpharma.com.
Contact InDex Pharmaceuticals:
Jesper Wiklund, CEO
Tel: +46 8 508 847 35/ +46 (0)733 59 05 53
Dr. Ludger Wess or Ines-Regina Buth
Tel.: +49 (0)40 88 16 59 64 / +49 (0)30 2363 2768