– Novel patent for Phase III lead drug candidate filed in the EU, US –
Stockholm, August 30, 2012 – InDex Pharmaceuticals today announced the filing of a new patent with the United States Patent and Trademark Office and with the European Patent Office. The company thereby continues to strengthen the company’s intellectual property portfolio around its lead drug candidate Kappaproct. The newly filed patent with the title “Methods for prevention of colectomy” covers methods of preventing or reducing the need of colectomy using an oligonucleotide with a specific core sequence and has the potential to extend patent protection on Kappaproct to 2032. Kappaproct is a DNA-based synthetic oligonucleotide, which functions as an immunomodulatory agent by targeting TLR9. Kappaproct is currently in a phase III study in Europe for the treatment of chronic, active, treatment-refractory ulcerative colitis. InDex Pharmaceuticals already holds broad patent protection for Kappaproct for the treatment of steroid-resistant inflammatory diseases in both Europe and US through at least 2027, with the possibility of a 3 to 5-year term extension after market approval.
“With our patent portfolio, we already have very solid protection for Kappaproct and this newly filed patent will even further broaden and strengthen our global intellectual property position”, said Jesper Wiklund, CEO of InDex Pharmaceuticals. “There is a significant unmet medical need for patients with gastrointestinal disease, who have tried all available therapies and whose only remaining option is highly invasive surgery. Successful treatment with Kappaproct would enable patients to avoid surgery and dramatically improve the lives and prospects of these very ill individuals”.
In June 2012, InDex Pharmaceuticals reported positive data from the Company’s compassionate use program with its lead compound Kappaproct. The findings published in the peer-reviewed journal Inflammatory Bowel Diseases showed that more than two years post treatment, all but one of the treated patients had avoided the need for colectomy, with the longest patient being in symptom-free remission for over 27 months.
Kappaproct is a single-strand, DNA-based synthetic oligonucleotide. It functions as an immuno- modulatory agent by targeting 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 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. In 2009, InDex Pharmaceuticals launched the diagnostic test DiBiCol in Sweden. DiBiCol differentiates between ulcerative colitis and Crohn’s disease, the two major forms of inflammatory bowel disease.
InDex Pharmaceuticals was founded in 2000 and is located in Stockholm, Sweden.
For additional information about 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