KARO BIO COMPLETES SUCCESSFUL PHASE I STUDY OF KB2115 AND PLANS FOR PHASE II DEVELOPMENT
All patients have been dosed in the Karo Bio phase Ib two-week multi-dose study with KB 2115. No adverse events were recorded, and KB2115 was well tolerated. Also, excellent bioavailability and pharmacokinetic properties were documented. The main findings will be reported during spring 2006, and the planning for phase II development continues.
In preclinical studies, KB2115 selectively stimulates the thyroid hormone receptor and thereby increases the body’s energy consumption and reduces body weight. The compound also markedly reduces blood lipids and blood glucose and has a broad therapeutic range.
The phase I study is a randomized, double-blind and placebo-controlled study in healthy but overweight males and females with dyslipidemia. The primary objective is to determine the short term safety and tolerability of single dose (phase Ia) and multiple oral doses of KB2115 administered daily over a two-week period (phase Ib).
Some of the main findings in the two-week study are:
• Excellent safety and bioavailability, no reported side effects
• No negative effects on the heart
• High bioavailability and linear pharmacokinetics
• Significant lowering of total and LDL cholesterol
“We are pleased with the outcome of the KB2115 phase Ib study. We will continue to prepare for further clinical development of the compound, and intend to present more data from the trial during a capital-markets day during spring of 2006”, says Per-Olof Wallström, President and CEO of Karo Bio.
KARO BIO AB
For further information, please contact:
Per Olof Wallström, President & Chief Executive Officer
Telephone: +46 8 608 60 20
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.