Tag: InDex Pharmaceuticals
Company News: InDex Pharmaceuticals Granted Japanese Patent for Novel Treatment of Steroid-Resistant Inflammation
InDex Pharmaceuticals today announced that it has been granted a Japanese patent by the Japan Patent Office (JPO). The patent provides protection for the use of Kappaproct® and other 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 “Immunostimulatory Method” covers the use of a broad range of oligonucleotides for the treatment of steroid resistance in patients afflicted with inflammatory conditions. It provides an exclusivity period until at least 2026, with the possibility of up to 5 years of patent term extension after market approval. InDex Pharmaceuticals already holds patent protection for Kappaproct for the treatment of steroid-resistant inflammatory diseases in both Europe and the US.
InDex Pharmaceuticals develops DIMS compounds – 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.
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: 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 Appoints Stig Løkke Pedersen as Board Member
– Former Lundbeck Executive Brings Strong Commercial Experience and Extensive Pharmaceutical Industry Network –
InDex Pharmaceuticals today announced that Stig Løkke Pedersen has been appointed as a new member of the Board of Directors. Mr. Pedersen brings to InDex Pharmaceuticals over 25 years of longstanding life sciences industry experience in commercial operations and leadership.
Mr. Pedersen previously served as Executive Vice President of Commercial Operations at H. Lundbeck A/S. He joined Lundbeck in January 1992, being responsible for the company’s business development activities. Following a period as Managing Director of Lundbeck Netherlands, he became part of the corporate senior management in 1998. Mr. Pedersen was appointed Executive Vice President in April 2003 and held the position as EVP for Commercial Operations from 2007 until June 2011, when he resigned from his position at Lundbeck. Mr. Pedersen is a Partner at Executive Capital A/S and serves as the Chairman of the Board of Directors at Chemometec A/S and Nuevolution A/S. He is a member of the Board of Directors at MSI Methylation Sciences Inc. and a member of the Advisory Board of Atrium Partners A/S and JSB-Partners, as well as an advisor to the Lundbeck Foundation.