Karo Bio Progress in Eprotirome (KB2115) Development
? Eprotirome approved as generic name for KB2115
? The continued clinical development of eprotirome is progressing according to plan. All patients in a new phase IIb study have been enrolled and the dosing has been initiated
? Important scientific data from Karo Bio’s first clinical study with eprotirome was recently published in the American Journal Proceedings of the National Academy of Sciences (PNAS). The publication received significant international attention.
HUDDINGE, Sweden, Jan. 17, 2008--Eprotirome (new generic name
for KB2115) is a new compound that lowers high blood lipid levels
by activating the thyroid hormone receptor in the liver. Data from
the first two week study in 24 patients with elevated cholesterol
levels have now been published in PNAS with the title “The
thyroid hormone mimetic compound KB2115 lowers plasma low density
protein (LDL) cholesterol without cardiac effects in
The results represent a break through in the field. For the first time it has been possible to show in man, that a drug that activate the thyroid hormone receptor can induce a significant lowering of blood cholesterol levels (up to 40%) without negative effects on the heart.
As previously reported in June last year Karo Bio has also completed a larger 12 week study on 99 patients with primary dyslipidemia. The results showed that eprotirome was effective with significant lowering of risk factors like total cholesterol, LDL cholesterol, triglycerides and lipoprotein(a). All patients responded to treatment and eprotirome was well tolerated.
The clinical phase IIb programme is now continuing with a study in 172 patients where eprotirome is given concomitantly with statins. All patients have been enrolled and the dosing has been initiated. Most high risk patients do not reach their LDL target levels with statin treatment alone. Thus, there is a great need for new and effective drugs like eprotirome.
“We are encouraged by the progress in the development of eprotirome and by the international attention our compound is receiving. The results from the ongoing phase IIb study will be crucial for our partnering plans and phase III development. We expect to present the key data during the third quarter of 2008”, says Per Olof Wallström, President of Karo Bio.
For further information, please contact:
Per Olof Wallström, President & Chief Executive Officer
Telephone: +46 8 608 6020
Per Otteskog, Senior Vice President
Telephone: +46 8 608 6018
Facts about Karo Bio
Karo Bio is a drug discovery and development company specializing in nuclear receptors for the development of novel pharmaceuticals with focus on metabolic diseases.
The company has expanded from being a drug discovery company by adding in-house preclinical and clinical development resources and competence for development of drugs to treat metabolic diseases. The company has a strong project portfolio with innovative molecules that primarily targets diseases such as diabetes, atherosclerosis and dyslipidemia. In all of these areas there are significant market opportunities and a growing need for new pharmaceuticals with new mechanisms of action.
In addition to the proprietary projects Karo Bio has two strategic collaborations with international pharmaceutical companies and one biotech collaboration 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). This press release is also available online at: www.karobio.se and www.newsroom.cision.com
Posted: January 2008