Additional analyses of data from COLLECT – a clinical study of InDex Pharmaceuticals Holding AB’s (publ) (STO:INDEX) lead drug candidate cobitolimod for the treatment of moderate to severe active ulcerative colitis – was orally presented and met with great interest at the United European Gastroenterology Week (UEGW) 2016 in Vienna.
“The results suggest that cobitolimod can induce clinical remission in patients with both moderate and severe ulcerative colitis. As expected the highest remission rates were obtained in patients with moderate disease activity, which is in line with other therapies in this indication,” said Professor Raja Atreya at the University of Erlangen-Nürnberg who was one of the study investigators and who presented the findings during a well attended session at UEGW, which is the largest scientific meeting for gastroenterologists in Europe.
In the COLLECT study, 131 patients with moderate to severe active ulcerative colitis, not responding to conventional therapy, received either cobitolimod or placebo in addition to standard of care treatment. The study was conducted at 38 centers in seven European countries.
“Cobitolimod is a very promising novel therapeutic option for this debilitating condition and I am now looking forward to start the next larger clinical phase IIb study with cobitolimod where I will be the principal investigator”, Professor Atreya continued.
The influence of disease activity on the therapeutic efficacy in COLLECT The presented post-hoc analyses divide the patients into three different subgroups by disease severity at study start, with 28%, 46% and 26% of the patients assigned to each respective subgroup. It shows that 32% of the patients in the cobitolimod group who had moderate ulcerative colitis at baseline achieved clinical remission at week 4, defined as absence of blood in the stool, stool frequency of less than 35 per week, and healing of the colonic mucosa, compared with 8% of patients who received placebo. Also, 22% of the patients in the cobitolimod group with moderate to severe disease activity at baseline achieved remission at week 4 compared to 0% of patients who received placebo. 9% of the patients in the cobitolimod group with severe ulcerative colitis at baseline achieved clinical remission at week 4 compared to 0% of the patients in the placebo group.
|Disease activity at study start||Share of patients||
Percentage in remission week 4
Percentage in remission week 4
|Moderate to severe||46%||22%||0%|
Poster will be presented October 19 On Wednesday October 19, a poster, entitled Clinical Efficacy of the Toll-like Receptor 9 Agonist Cobitolimod in Anti-TNF-antibody Treated and Naïve Patients with Moderate to Severe Active Ulcerative Colitis, will be presented by Professor Atreya as Poster of Excellence in the Poster Champ session. This subgroup analysis shows that cobitolimod can induce clinical remission both in patients who have previously tried anti-TNF-alpha therapy and in those who have not tried anti-TNF-alpha therapy.
39% of the patients in the COLLECT study had previously been treated with anti-TNF-alpha therapy. As expected, the absolute remission rates were higher in patients who had not tried anti-TNF-alpha therapy. 28% of patients in the cobitolimod group who had not tried anti-TNF-alpha therapy achieved clinical remission at week 4, defined as absence of blood in the stool, stool frequency of less than 35 per week, and healing of the colonic mucosa, compared with 0% in the placebo group. For patients who had received prior therapy with anti-TNF-alpha, 10% of the patients in the cobitolimod group achieved clinical remission at week 4 compared with 6% in the placebo group.
Published main results support the potential of cobitolimod Main results from the COLLECT study were recently published in the Journal of Crohns and Colitis (Atreya et al. J Crohns Colitis 2016 May 20 Epub ahead of print). The results support the potential of cobitolimod as a novel treatment for moderate to severe active ulcerative colitis. Statistically significant differences between cobitolimod and placebo were observed already after four weeks in several important efficacy endpoints currently recommended by regulatory authorities and considered as the most clinically relevant.
"We are pleased that our results continue to meet considerable interest from the medical expertise as we now continue the work of taking our lead drug candidate cobitolimod through the next value increasing phase", says Peter Zerhouni, CEO of InDex Pharmaceuticals.
Abstracts of the UEGW presentations are available through the UEGW App.
Cobitolimod in brief Cobitolimod is a new type of drug that can help patients with moderate to severe ulcerative colitis back to a normal life. It is a so-called Toll-like receptor 9 (TLR9) agonist, that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. Cobitolimod has achieved clinical proof-of-concept in moderate to severe active ulcerative colitis, with a very favorable safety profile. Data from four placebo-controlled clinical trials indicate that cobitolimod has statistically significant effects on those endpoints that are most relevant in this disease, both from a regulatory and clinical perspective. These endpoints include the key clinical symptoms such as blood in stool, number of stools, and mucosal healing, respectively. Cobitolimod is also known as Kappaproct® and DIMS0150.
InDex Pharmaceuticals in brief InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company’s foremost asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe active ulcerative colitis - a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in treatment of various immunological diseases.
InDex is based in Stockholm, Sweden. The company’s shares are traded on Nasdaq First North Stockholm since the 11th of October, 2016. Redeye AB is the company’s Certified Adviser. For more information, please visit www.indexpharma.com
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Last updated on: 18/10/2016
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