Tag: COLLECT study
Company News: InDex Pharmaceuticals Reports Completion of Patient Recruitment in Phase III Ulcerative Colitis Study (COLLECT) with Kappaproct®
InDex Pharmaceuticals today announced the completion of patient enrollment for its Phase III COLLECT study of Kappaproct. The multinational, randomized, double-blind, placebo-controlled study reached the recruitment goal of 120 patients with treatment-refractory Ulcerative Colitis (UC). InDex is expecting final study results in mid-2014.
The Phase III trial is designed to assess Kappaproct’s efficacy and safety in treatment-refractory UC patients. This cohort consists of chronic active UC patients who have failed all currently available pharmaceutical treatment and whose only remaining treatment option is surgical removal of the colon. This is a rare group of patients with a very high unmet medical need. Kappaproct has an Orphan Drug Designation in Europe.
The study is conducted in seven European countries. The primary endpoint of the study is the induction of clinical remission at week 12. Secondary endpoints, among others, are the rate of and time to colectomy. The patients will be followed for a total of 52 weeks.
Kappaproct is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9). Kappaproct has shown positive effects on key symptoms of UC such as stool frequency, blood in stool and mucosal healing in a previous phase II proof-of-concept study. Kappaproct has also demonstrated a favorable safety and side effect profile in previous clinical trials.
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 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.
Company News: InDex Pharmaceuticals Expands Management Team
– InDex Pharmaceuticals Names Pernilla Sandwall Head of Clinical Operations and Thomas Knittel Chief Medical Officer –
Stockholm, April 11, 2012 – InDex Pharmaceuticals today announced two additions to its management team: Pernilla Sandwall has been appointed as Head of Clinical Operations and Thomas Knittel as Chief Medical Officer. Pernilla Sandwall will lead the company’s clinical development team, with the main focus being the ongoing phase III clinical trial of Kappaproct® in patients with treatment-refractory ulcerative colitis. Thomas Knittel will serve as the company’s lead medical expert and provide leadership in medical and marketing affairs.
Pernilla Sandwall has more than 20 years of experience in clinical research operations. She joins InDex Pharmaceuticals from Merck & Co. Inc. (MSD), where she has worked both in the Swedish subsidiary and the U.S. headquarters, as well as regionally in Europe. She has experience in the field as CRA and project manager, as well as strategically as Clinical Research Manager. Her focus over the last years has been global patient recruitment, site selection strategies and execution. She also has experience in change management and Lean Six Sigma methodology. She has a Master of Science in Pharmacy from Uppsala University.
Thomas Knittel has over 15 years of clinical experience within gastroenterology as well as 13 years of experience in medical affairs and marketing management. Before joining InDex Pharmaceuticals, he held positions as Business Unit Director and Director of Sales and Marketing at Novo Nordisk for central Europe, as General Manager Pharmaceuticals at Harlan Laboratories, and as Vice President Corporate and Medical Affairs at Develogen AG. He has a Medical degree from the University of Mainz with a specialist training in internal medicine and gastroenterology. He is an Associate Professor in Internal Medicine and Gastroenterology at the University Clinic Goettingen. In addition, he has an MBA from Kellogg School of Management/WHU.