Stockholm, April 26, 2012 – InDex Pharmaceuticals today announced that it has been granted a patent by the United States Patent and Trademark Office (USPTO). The patent provides additional protection for the use of Kappaproct and additional DNA-based immunomodulatory sequences (DIMS) for the treatment of steroid-resistant inflammatory diseases including inflammatory bowel disease, rheumatoid arthritis, psoriasis, asthma, emphysema and chronic obstructive pulmonary disease.
The patent, entitled “Method for Modulating Responsiveness to Steroids” covers a method for enhancing steroid efficacy in steroid-refractory patients afflicted with an inflammatory condition using oligonucleotides with a specific common core sequence. It provides an exclusivity period until June 2027 with the possibility of a 3 to 5-year term extension after market approval. A corresponding European patent was granted in August 2009.
“We are pleased that the USPTO has recognized the importance and patentability of our discoveries for the treatment of steroid-resistant inflammation,” said Jesper Wiklund, CEO of InDex Pharmaceuticals. “This newly granted US patent is an important value driver for InDex since we now have exclusivity for Kappaproct in the US beyond 2030. Moreover, it further strengthens the US intellectual property position of our technology platform. Steroid-resistant diseases represent areas of substantial unmet medical need and this patent provides the company with protection in this high value area.”
InDex Pharmaceuticals develops DIMS compounds that are synthetic oligonucleotides that function as immunomodulatory agents by targeting the Toll-like receptor 9 (TLR9). The company’s most advanced DIMS product candidate, Kappaproct, is currently in a phase III study in Europe for the treatment of chronic, active, treatment-refractory ulcerative colitis.
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 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. 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