Tag: ulcerative colitis (UC)
Company News: InDex Pharmaceuticals announces results from COLLECT, a clinical trial of Kappaproct® in the treatment of moderate to severe Ulcerative Colitis
InDex Pharmaceuticals today reported top-line results from the double blind, placebo-controlled clinical study COLLECT. The aim of the COLLECT study was to investigate the therapeutic potential of the Toll-like receptor 9 agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis.
Patients treated with Kappaproct showed statistically significant improvement on symptomatic remission (blood in stool, number of stools), registration remission (clinical remission with concurrent endoscopic remission) and the rate of colectomy. The rate of clinical remission (Rachmilewitz Index) was high in both the Kappaproct and the control group and no statistically significant difference was observed on this measure. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident.
In the COLLECT study, 131 patients with moderate to severe Ulcerative Colitis with inadequate response to conventional therapy received either Kappaproct or placebo as an add-on to conventional treatment. Concominant use of TNF-α inhibitors was excluded. The study was conducted at 40 sites in seven European countries.
Kappaproct was administrated as two single rectal doses, given at week 0 and week 4. The primary endpoint was clinical remission (Rachmilewitz/CAI score of ≤4) measured at week 12. There was an unexpectedly high remission rate in the control group and there was no statistically significant difference observed on this measure. Statistically significant effects were demonstrated on the secondary endpoints symptomatic remission (blood in stool = none, number of stools weekly <35) at week 4 and 8, on registration remission (Rachmilewitz/CAI score of ≤4, plus an endoscopic Mayo score of 0 or 1) at week 4 as well as on the rate of colectomy at week 22. The patients were followed for one year from the first dose to evaluate long-term efficacy and safety. More information about the study can be found on clinicaltrials.gov.
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.
Company News: InDex Pharmaceuticals Closes $20 m Financing Round, Welcomes NeoMed as New Shareholder
InDex Pharmaceuticals today announced the successful closing of a USD 20 million / EUR 15 million new rights issue. NeoMed led the oversubscribed financing round while current shareholders participated with 75% of the invested capital.
In summer 2014, InDex Pharmaceuticals expects to report data from a Phase III study with its lead product candidate Kappaproct®, which is being developed for the treatment of severe Ulcerative Colitis (UC) – a debilitating, chronic inflammation of the large intestine.
In conjunction with the investment, Dr. Erik Amble, Managing Partner and founder of NeoMed Management, has been appointed as a new member of the company’s Board of Directors. Dr. Amble has over 25 years of experience with venture capital investments in Europe and the U.S.
Since 2012, Kappaproct® has been investigated in the COLLECT trial, a European multicenter Phase III study to evaluate the effectiveness and safety for the treatment of chronic active, refractive ulcerative colitis (UC) patients. Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9). Primary endpoint of the COLLECT study is induction of clinical remission in severe UC patients, who have failed all other medical treatments and whose only remaining treatment option is colectomy.