KARO BIO INITIATES THE FIRST PHASE II STUDY WITH KB2115

The Swedish and Finnish Medical Product Agencies have approved the first phase II clinical study with KB2115 for the treatment of dyslipidemia. The primary objective of the study is to determine efficacy and safety in patients with primary hypercholesterolemia. Recruitment of patients for this three month, multi center study in Sweden and Finland has now been initiated.

It is well established that medical treatments that lower serum cholesterol and blood lipids significantly reduce cardiovascular events and mortality. In particular statins are widely used for lowering of LDL (bad cholesterol). However, with new and more aggressive guidelines for cholesterol lowering, an increasing number of patients do not reach treatment objectives. Thus, there is a need for new and more efficacious drugs and therapeutic principles that can be used as single therapy or in combination with statins.

KB2115 is a selective thyroid hormone receptor modulator that in previous phase I studies has shown satisfactory pharmacokinetic and bioavailability properties without exposing patients to severe adverse reactions. In a two week phase I study, KB2115 also induced a significant lowering (up to 40%) of LDL cholesterol. In the upcoming phase II study, Karo Bio will further assess the efficacy and safety of KB2115 in a total of 100 patients with primary hypercholesterolemia. The study will be a three month, placebo controlled, double blind and randomised multi centre study in Sweden and Finland.

“We are excited about the profile of KB2115 which represents the first compound from Karo Bio’s research entering phase II studies”, says Per Olof Wallström, President of Karo Bio. “This is a landmark for the company, and confirms our strategy to drive projects further into clinical development before potential partnering negotiations. This study will give us many answers to efficacy and safety parameters, and will be a corner stone in the future clinical development of KB2115”.

KARO BIO AB

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

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

Facts about Karo Bio
Karo Bio is an innovative drug discovery and development company specializing in nuclear receptors for the development of novel pharmaceuticals with focus on metabolic diseases.
Karo Bio is listed on the Stockholm stock exchange (Reuters: KARO.ST) since 1998.

The Company has expanded from being a drug discovery company by adding in-house preclinical development resources and competence for development of drugs to treat metabolic diseases. The Company has a strong project portfolio primarily targeting diseases such as diabetes, obesity, atherosclerosis and dyslipidemia.

In addition, Karo Bio has two strategic collaborations with international pharmaceutical companies for development of innovative therapies for the treatment of common diseases.

This press release is also available online at: www.karobio.com and www.waymaker.net.