Tag: ulcerative colitis
Company News: InDex Pharmaceuticals regains European rights to Kappaproct® in ulcerative colitis
InDex Pharmaceuticals today announced the termination of a license agreement with Almirall S.A. relating to the drug candidate Kappaproct® for the treatment of ulcerative colitis. Under the agreement, which was signed in March 2014, Almirall licensed exclusive rights to Kappaproct® for the European market. Upon termination of the agreement, InDex regains all worldwide development and commercialization rights for Kappaproct®, which is in late-stage clinical development.
The termination of the agreement follows Almirall’s recent repositioning of their R&D organization to leverage strong formulation capabilities and high-quality New Chemical Entities (NCEs) in Dermatology. Almirall has communicated that their new strategy is to become a leading specialty pharmaceutical company with a strong focus on improving the lives of Dermatology patients and that the company will use its strong cash position to fund growth opportunities in this direction.
Kappaproct® is InDex Pharmaceutical’s lead drug candidate and is in late-stage clinical development for moderate to severe ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) that targets the toll-like receptor 9 (TLR9). The recent COLLECT study was conducted in seven European countries and included 131 patients with moderate to severe ulcerative colitis with inadequate response to conventional therapy. They received either Kappaproct® or placebo in addition to conventional treatment. Kappaproct® demonstrated statistically significant effects on endpoints that are highly relevant both from a regulatory and clinical perspective such as key clinical symptoms, i.e. blood in stool and number of stools, and mucosal healing. The primary endpoint of clinical remission at 12 weeks using the CAI score was not met due to an unexpectedly high placebo rate for this endpoint. The next clinical study with Kappaproct® is currently being planned in discussion with EU and US regulatory agencies.
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: 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.