Tag: DNA-based immunomodulatory sequence (DIMS)
Company News: InDex Pharmaceuticals and Almirall enter into a license agreement for European rights of the phase III drug candidate Kappaproct®
InDex Pharmaceuticals and Almirall announced today that they have signed a license agreement for the European marketing rights to the drug candidate Kappaproct®. Under the terms of the agreement, InDex is eligible for an upfront payment as well as success driven milestone payments with a total deal value that could exceed EUR100M. InDex is also entitled to receive double digit royalties from Almirall on the European net sales of Kappaproct®.
InDex Pharmaceutical’s lead drug candidate Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) that targets the toll-like receptor 9 (TLR9). Kappaproct is a potential treatment for severe Ulcerative Colitis (UC), a debilitating, chronic inflammation of the large intestine. The results from the ongoing Phase III trial COLLECT are expected in mid-2014.
– 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: Kappaproct Drastically Reduces the Need for Colectomy in Patients with Severe Ulcerative Colitis
– InDex Pharmaceuticals reports positive clinical data in peer-reviewed journal Inflammatory Bowel Diseases –
InDex Pharmaceuticals today announced the publication of positive data from the Company’s compassionate use program with its lead compound Kappaproct. In the program, eight treatment-refractory ulcerative colitis (UC) patients that had been elected for colectomy received Kappaproct, a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9).
The findings showed that Kappaproct induced a pronounced and rapid reduction in the colitis activity index for all treated patients within 1 week following a single intracolonic administration. Further improvements were evident at week 4, resulting in a clinical response rate after a single-dose treatment with Kappaproct of 71%, with 43% in clinical remission. By week 12, the clinical response and remission rates had reached 82% and 71%, respectively. A follow-up period of over 2 years post treatment indicated that 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.
The article “Topical Treatment with the Toll-like Receptor Agonist DIMS0150 Has Potential for Lasting Relief of Symptoms in Patients with Chronic Active Ulcerative Colitis by Restoring Glucocorticoid Sensitivity”, was published in the journal Inflammatory Bowel Diseases (DOI 10.1002/ibd.23019).
Kappaproct is currently in a European multicenter phase III trial called COLLECT (NCT01493960) for the treatment of chronic active UC patients not responding to available therapy. Results are expected for Q1 2014.
Company News: InDex Pharmaceuticals Granted US Patent for Novel Treatment of Steroid-Resistant Inflammation
InDex Pharmaceuticals today announced that it has been granted a patent by the United States Patent and Trademark Office. 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.
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.