KARO BIO PRESENTS PHASE III CLINICAL TRIALS DESIGN FOR EPROTIROME
STOCKHOLM, Sweden, August 26, 2010. Karo Bio AB (publ) (Reuters: KARO.ST) today presents its development plan for the phase III studies of eprotirome as a novel pharmaceutical for the treatment of high-risk patients with heterozygous familial hypercholesterolemia (HeFH).
There is currently no sufficient treatment available for a majority of HeFH patients. In several clinical phase II studies, eprotirome has shown to have a very compelling efficacy profile for the lowering of blood lipid levels. The planned clinical phase III program is designed to evaluate eprotirome’s safety profile at longer treatment regimens, as well as its efficacy profile in HeFH patients.
The clinical phase III development plan for eprotirome (KB2115) for the indication HeFH will be presented by Dr. Jens Kristensen, Karo Bio’s Chief Medical Officer at a seminar this afternoon. “Our quest is that Karo Bio through these studies will be able to present a better treatment option for HeFH patients, to significantly lower the cardiovascular risk they have to live with today. We believe that developing eprotirome for the HeFH indication will be a relatively fast path to make this novel drug available for patients with a clear medical need,” says Dr. Jens Kristensen.
The clinical phase III trials will involve between 625 and 1,150 patients under treatment for 12-18 months. The primary endpoint is to show clinically relevant lowering of LDL- cholesterol in addition to standard treatment of care, normally statins. The trials will be carried out at 30-50 centers in a number of European countries and are planned to commence in 2011. Provided that the development program progresses according to plan, an application for approval will be submitted to the European Medicines Agency EMA in late 2013 or in 2014.
John J.P.Kastelein, Professor of Medicine and Chairman of the Department of Vascular Medicine at Academic Medical Center in Amsterdam, Netherlands, will be the principal investigator for the clinical trial in HeFH. Steven E. Nissen, Professor of Medicine and Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic in Ohio, USA, will chair the clinical program’s steering committee.
In connection to Dr. Kristensen’s presentation this afternoon, Professors Steven E. Nissen and John J.P. Kastelein will share their insights on the regulatory landscape for dyslipidemia drugs and clinical testing of pharmaceuticals for HeFH.
The seminar takes place today, Thursday August 26 at 16.00 (4 pm) in the Lecture Hall on the 4th floor at Karolinska Institute, Novum, Huddinge, Sweden. To attend, please contact Eva Kruse at eva.kruse@karobio.se or by phone +46 8 608 6027.
Highlights of the presentations from the seminar will be available in on www.karobio.com from Friday, August 27, 2010.
For further information please contact
Fredrik Lindgren, CEO
Mobile: +46 705 616 177
Erika Söderberg Johnson, CFO
Mobile: +46 70 720 48 20
About eprotirome
The thyroid hormone is one of the body’s own ways of regulating lipids in the blood. This effect is exercised in the liver. Eprotirome is a novel, liver-selective thyroid hormone receptor agonist for the treatment of dyslipidemia. Eprotirome’s profile is unique. In one single compound, powerful reductions of several independent risk factors for the development of atherosclerotic cardiovascular diseases are combined.
About heterozygous familial hypercholesterolemia (HeFH)
HeFH is a hereditary condition where patients suffer from very high blood lipid levels already in early years. HeFH patients are therefore a high-risk group for cardiovascular disease. The prevalence is estimated to between 1 of 350 to 1 of 500 people globally. In total, it is Karo Bio’s estimation that there are about 1 million patients in Europe alone, and as many in the US and Japan combined. Like other dyslipidemia patients, HeFH patients are mainly treated with statins. Only about 20-30% of the patients reach their treatment goals. Today, the degree of diagnosis of HeFH is about 15%, which is expected to grow substantially when existing gene tests and DNA mapping are becoming more recurrent.
About Karo Bio
Karo Bio is a pharmaceutical company focused on the research and development of innovative drugs for unmet medical needs. Karo Bio’s vision is to become a pharmaceutical company with sustainable profitability, products on the market and a competitive project portfolio.
Karo Bio runs a number of development projects within the indication areas cardiovascular and metabolic diseases, neuropsychiatry, inflammation, cancer and women’s health. An important foundation for the company’s activities is the unique knowledge around nuclear receptors as target proteins for the development of novel pharmaceuticals, as well as the related mechanisms of action. Important processes and competences within the company are structurally based research, drug discovery, preclinical and clinical development, and medical and regulatory expertise.
Kar Bio has the capability to take selected compounds for niche indications through the whole development chain, while compounds addressing large patient groups require development collaborations or out-licensing at some stage in the process. In addition to the proprietary projects, Karo Bio has three strategic collaborations with international pharmaceutical companies.
Karo Bio, headquartered in Huddinge, has 70 employees, and is listed on NASDAQ OMX Stockholm since 1998 (Reuters: KARO.ST).
This press release is also available online at: www.karobio.com and www.newsroom.cision.com