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2016-10-18

Index Pharmaceuticals: Results from InDex Pharmaceuticals' COLLECT study well received at UEGW

October 18, 2016 - Additional analyses of data from COLLECT - a
clinical study of InDex Pharmaceuticals Holding AB's (publ) 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 |Share of|Cobitolimod |Placebo |
|activity at|patients|Percentage in |Percentage in remission week 4|
|study start| |remission week 4| |
+-----------+--------+----------------+--------------------------------+
|Moderate |28% |32% |8% |
+-----------+--------+----------------+--------------------------------+
|Moderate to|46% |22% |0% |
|severe | | | |
+-----------+--------+----------------+--------------------------------+
|Severe |26% |9% |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.

For more information:
Peter Zerhouni, CEO
Phone: +46 8 508 847 35
E-mail: peter.zerhouni@indexpharma.com

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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http://news.cision.com/index-pharmaceuticals/r/results-from-index-pharma...
http://mb.cision.com/Main/9612/2102872/576095.pdf

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