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2017-02-01

Index Pharmaceuticals: InDex Pharmaceuticals enters agreement with CRO for the CONDUCT study

February 1, 2017 - InDex Pharmaceuticals Holding AB (publ) today
announced that the company has entered an agreement for services with
the global contract research organization (CRO) PAREXEL for the
implementation of the CONDUCT study. CONDUCT is a phase IIb dose
optimisation study with the drug candidate cobitolimod for the
treatment of moderate to severe active ulcerative colitis.

According to the agreement, the first patient in the CONDUCT study
will be enrolled during the second quarter of 2017 and the objective
is to have top line results from the study in the fourth quarter of
2018. The study will be conducted at approximately 90 sites in 12
different countries: Czech Republic, France, Germany, Hungary, Italy,
Poland, Romania, Russia, Serbia, Spain, Sweden and Ukraine. Many
sites would like to participate and of more than 100 visted
interested sites, 60 have already qualified to take part in the
study. The process of getting the study approved by regulators and
ethics committees in each country is underway. The study will not
include any US sites due to the high cost per patient.

"We are very pleased to have PAREXEL as our partner for this important
trial with cobitolimod, our lead drug candidate", says Peter
Zerhouni, CEO of InDex Pharmaceuticals. "It is a leading global CRO
with considerable experience from managing multinational clinical
studies in inflammatory bowel disease. We are now working together to
advance the CONDUCT study as efficiently and quickly as possible."

The CONDUCT study will include 215 patients with left-sided moderate
to severe active ulcerative colitis, divided into four treatment arms
receiving cobitolimod and one arm receiving placebo. It is a
randomised, double blind, placebo controlled study for evaluating
cobitolimod's efficacy and safety in inducing clinical remission
compared to placebo. In addition to cobitolimod or placebo, all
patients will receive standard of care treatment.

Based on the promising results of earlier clinical trials with
cobitolimod this study will evaluate other doses and dose frequencies
than previously investigated in order to optimise the treatment. The
goal is, while maintaining the compound's excellent safety profile,
to show a substantially higher efficacy than in prior studies and
also in comparison with what has been reported for drugs on the
market as well as other compounds in late stage clinical development.

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. Redeye AB is the company's Certified
Adviser. For more information, please visit www.indexpharma.com

Publication
This information is information that InDex Pharmaceuticals Holding AB
(publ) is obliged to make public pursuant to the EU Market Abuse
Regulation and/or the Swedish Financial Instruments Trading Act. The
information was submitted for publication through the agency of the
contact person set out above at 8:00 CET on February 1, 2017.

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http://news.cision.com/index-pharmaceuticals/r/index-pharmaceuticals-ent...
http://mb.cision.com/Main/9612/2177796/621842.pdf

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