Tag: Jesper Wiklund

Company News: InDex Pharmaceuticals Strengthens IP Position for Kappaproct

– Novel patent for Phase III lead drug candidate filed in the EU, US –

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 for 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 the US through at least 2027, with the possibility of a 3 to 5-year term extension after market approval.

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.

Company News: InDex Pharmaceuticals Starts Phase III COLLECT Study with Kappaproct®

– TLR9 Agonist for the Treatment of Chronic, Active, Treatment-Refractory Ulcerative Colitis –

InDex Pharmaceuticals today announced the start of the COLLECT trial, a European multicenter Phase III study to evaluate the effectiveness and safety of Kappaproct for the treatment of chronic active ulcerative colitis (UC) patients not responding to available therapy. Kappaproct is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9).

UC 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 still exists for patients with severe UC. Many of these patients have failed all available pharmaceutical therapies – therefore, surgical removal of the colon by partial or complete colectomy is currently the only remaining treatment option.

The primary endpoint of the COLLECT study is induction of clinical remission in these severe UC patients, who have failed all other medical treatments and have been elected for colectomy. Preliminary results are expected for Q1, 2014.

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