KARO BIO ANNOUNCES SUCCESSFUL PHASE II STUDY WITH EPROTIROME IN COMBINATION WITH STATIN


KARO BIO ANNOUNCES SUCCESSFUL PHASE II STUDY WITH EPROTIROME IN COMBINATION WITH
STATIN

Karo Bio has successfully completed a 12 week phase IIb study of eprotirome
(KB2115) given to patients with dyslipidemia (elevated blood lipids).  These
patients were already on statin treatment. Data show that eprotirome induced a
statistically significant and clinically relevant lowering of serum
LDL-cholesterol, triglycerides and lipoprotein (a) and was safe and well
tolerated. The data indicate that eprotirome has the potential to become an
important new medicine for treatment of dyslipidemia.

Eprotirome is a novel, selective, thyroid hormone receptor agonist, developed
for treatment of dyslipidemia. To explore the potential for eprotirome as an
add-on  to standard statin treatment, Karo Bio conducted a phase IIb placebo
controlled, randomized, double blind, 12 week study in 189 patients, each with
high levels of serum cholesterol. Three different doses of eprotirome were
tested on a background of statin treatment.

The results show that eprotirome, in a dose-dependent manner, significantly
lowered LDL-cholesterol, triglycerides and lipoprotein(a) when added to statin.
The additional reductions are clinically relevant and of the same magnitude as
eprotirome given alone. Eprotirome was safe and well tolerated. Sensitive
markers of the body's thyroid hormone status were unaffected by eprotirome. 

The profile of eprotirome is unique in producing simultaneous and powerful
reductions of three independent risk factors for the development of
atherosclerotic cardiovascular disease. This combined effect on LDL-cholesterol,
triglycerides and lipoprotein(a)  indicates that eprotirome has the potential
for being an important drug for dyslipidemia. Scientific data from the study
will be presented at upcoming conferences during the fall of 2008.

“The study shows that eprotirome can be given safely with statins, and has
significant therapeutic efficacy on LDL-cholesterol, triglycerides and
lipoprotein(a) over and above the effect of statin. The unique clinical
efficacy, tolerability and safety make this combination a potentially attractive
therapy for patients who cannot achieve their treatment goals with statin alone.
Karo Bio will proceed with its communicated strategy with the aim to develop
eprotirome through phase III with a partner” says Per Olof Wallström, President
of Karo Bio.







For further information, please contact:
Per Olof Wallström, President & Chief Executive Officer 
Phone: +46 8 608 60 20

Per Otteskog, Senior Vice President Investor Relations
Phone: +46 8 608 60 18


About dyslipidemia treatment and opportunities for eprotirome
Consequences of atherosclerotic cardiovascular disease such as coronary heart
disease and stroke are major medical problems, and there is a need to develop
improved means to treat these disorders by reducing important risk factors such
as serum LDL-cholesterol, triglycerides and lipoprotein(a).

Statins are a class of compounds that are widely used for treatment of elevated
LDL-cholesterol. The global sales of statins were in the range of USD 15-20
billion in 2007.  In spite of active treatment of high blood lipids with
increasing doses of statins over the last 15 years, and achieving subsequent
reductions of heart disease and stroke by some 30%, the morbidity and mortality
for cardiovascular atherosclerotic disease remain high. The treatment goals for
acceptable LDL-cholesterol levels have been generally lowered over the years,
specifically for high risk patients. Combination therapies have become more
common as it proves difficult to reach the treatment target by one medication
only. Apart from LDL-cholesterol there is a growing awareness that it is
important to lower additional risk factors such as triglycerides and
lipoprotein(a). Recent data indicate that lipoprotein(a) is a risk factor for
heart disease and stroke of the same magnitude as high blood pressure. Until now
there have been limited treatment options for patients with elevated
lipoprotein(a).

Eprotirome has the potential to be used as second-line therapy for patients who
do not reach their treatment goal with statin alone. Due to the combined effect
on LDL-cholesterol and triglycerides, eprotirome may be well suited for the
treatment of mixed dyslipidemia (elevated LDL-cholesterol and triglycerides) and
diabetic dyslipidemia. Further, eprotirome may provide a powerful treatment
option for patients with high levels of lipoprotein(a).


About Karo Bio 
Karo Bio is a drug discovery and development company specializing in nuclear
receptors for the development of novel pharmaceuticals. 
The Company has a strong project portfolio with innovative molecules that
primarily target metabolic diseases such as diabetes, atherosclerosis and
dyslipidemia. In all of these areas there are significant market opportunities
and a need for pharmaceuticals with new mechanisms of action. Karo Bio intends
to bring selected compounds within niche therapeutic areas into late stage
clinical develop¬ment and, potentially, to the market. In addition to pursuing
niche opportunities, Karo Bio continues to develop compounds aimed at treatment
of broad patient populations to clinical proof of concept before out licensing.
In addition to the proprietary projects, Karo Bio has three strategic
collaborations with international pharmaceutical companies for development of
innovative therapies for the treatment of common diseases.
Karo Bio is listed on the OMX Nordic Exchange Stockholm since 1998 (Reuters:
KARO.ST).



This press release is also available online at: www.karobio.com and
www.newsroom.cision.com

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