KARO BIO STRENGTHENS EPROTIROME PHASE II PROGRAM WITH ADDITIONAL CLINICAL STUDY

KARO BIO STRENGTHENS EPROTIROME PHASE II PROGRAM WITH ADDITIONAL CLINICAL STUDY

Karo Bio initiates the second clinical phase IIb dose ranging study with
eprotirome. This study will be conducted in dyslipidemia patients receiving
concomitant treatment with the cholesterol absorption inhibitor ezetimibe. 

The first phase IIb study in 180 patients where eprotirome is given in addition
to statin treatment is progressing according to plan. 


Karo Bio's compound eprotirome is a novel, selective, thyroid hormone agonist
for treatment of dyslipidemia. In a first phase IIa study, eprotirome induced a
significant LDL-cholesterol lowering of 25-30% in dyslipidemia patients.
Furthermore, eprotirome significantly reduced other risk factors for development
of cardiovascular disease such as triglycerides and lipoprotein(a), and was well
tolerated.

Eprotirome has a promising profile for treatment of dyslipidemia, either alone
or in combination with other dyslipidemia drugs. Currently eprotirome is given
in addition to simvastatin or atorvastatin in the first phase IIb dose ranging
study in 180 patients. This study is progressing according to plan and the
results will be available in the third quarter of 2008. 

The intention with the new phase IIb dose ranging study is to expand the
clinical and commercial potential for eprotirome in dyslipidemia treatment by
exploring whether eprotirome in combination with ezetimibe can serve as an
alternative to statin treatment. Ezetimibe is a well documented cholesterol
absorption inhibitor and thus complements eprotirome well with a different
mechanism of action.  The study is a placebo controlled, parallel group, double
blind, 10 week study dose ranging study in 100 patients. Eprotirome is given
once daily in doses of 25, 50, or 100 µg in addition to 10 mg per day of
ezetimibe. The results of the study are expected in the fourth quarter of 2008.

“Eprotirome has potential to become a major drug in the treatment of high blood
lipids. The broad and unique efficacy profile affecting several independent risk
factors for the development of cardiovascular disease, in combination with good
tolerability and safety, makes eprotirome a very attractive therapeutic option,
either as a single agent or in combination with statins or ezetimibe. With this
phase II program we are positioning eprotirome for partnership negotiations and
phase III clinical studies”, says Per Olof Wallström, President of Karo Bio. 


Facts about the market for dyslipidemia treatment
Elevated blood lipids (dyslipidemia) significantly correlate with development of
cardiovascular disease. In particular high plasma levels of the harmful
LDL-cholesterol contribute to disease development. Statins are an effective
class of drugs that is widely used for treatment of dyslipidemia. Still, there
is a great need for new dyslipidemia drugs that can be used together with
statins since a significant part of the patients do not reach the treatment
goals on single therapy or are intolerant to or unresponsive to statin
treatment. The trend is therefore to combine statin treatment with other
pharmaceuticals in order to reach desirable effects Combinations with
cholesterol absorption inhibitors, like ezetimibe, have been successful but
there is still a great need for new treatment options. 

The total dyslipidemia market has annual sales around USD 30 billion, whereof 
the statin class of drugs account for USD 25 billion. 


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

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


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 targets metabolic diseases such as diabetes, atherosclerosis and
dyslipidemia. In all of these areas there are significant market opportunities
and a need for new pharmaceuticals with new mechanisms of action. Karo Bio
intends to bring selected compounds within niche therapeutic areas into late
stage clinical development 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 AB since 1998 (Reuters:
KARO.ST).