Karo Bio releases an update on the clinical development of thyroid hormone analogue kb002611

KARO BIO RELEASES AN UPDATE ON THE CLINICAL DEVELOPMENT OF THYROID HORMONE ANALOGUE KB002611 Skin atrophy is a condition where the skin becomes thin and looses some of its function. The negative consequences are easy bruising and impaired wound healing. Skin atrophy results from topical treatment with corticosteroids but can also be caused by aging or sun exposure. In the atrophied skin there is a marked reduction of collagen, a protein which plays an important role for skin structure. Karo Bio has previously demonstrated in animal models that analogues of thyroid hormone, including KB002611, can restore collagen production (measured as formation of procollagen) after exposure to strong steroids. Through a series of United States patents and pending European patent applications, Karo Bio has a strong intellectual property portfolio related to formulations of thyroid hormone analogues, such as KB002611, in dermatological applications. Karo Bio has performed two clinical dermatology studies with drug candidate KB002611. These clinical studies were designed to determine whether topical treatment with this thyroid hormone analogue (KB002611- cream preparation) has activity in human skin for the treatment of skin atrophy. The first study was a mechanistic one conducted in healthy volunteers that were initially treated with a potent corticosteroid followed by one of either three different cream formulations; one high dose formulation of KB002611, one low dose formulation of KB002611 or a placebo- formulation. When evaluated by increased production of procollagen in the skin, Karo Bio's studies have demonstrated a substantially better effect of KB002611-treatment when compared to a placebo cream; furthermore, the lower-dose preparation appeared to be more effective than the higher-dose formula. The second clinical study was conducted in parallel with the study described above. In this study, Karo Bio sought to determine if KB002611 could reverse the deleterious effects of skin damaging agents such as potent topic corticosteriods. An important parameter in the diagnosis of skin atrophy and thus the assessment of skin atrophy is skin-thickness, which was selected as the primary parameter for evaluating KB002611. A high-dose formulation of KB002611 and a placebo preparation were compared in patients that had previously been treated with potent corticosteroids for certain medical conditions. A non-invasive technique (sonography) was used to measure skin thickness during the study and skin biopsies were taken to evaluate changes in skin morphology. Based upon the sonograhic data, there was no apparent difference between KB002611-treatment and placebo-treatment. However, the examination of the biopsies has not been completed and will be necessary before final conclusion can be drawn from this particular study. Treatment with KB002611 seems to have been safe and well tolerated in both studies. No hematology, clinical chemistry or thyroid hormone laboratory measurements suggested a systemic effect of the treatments. Based on the final result of the study Karo Bio will decide whether to seek partnership or choose to further develop the project internally. Huddinge, October 9, 2001 KARO BIO AB (publ) For further information contact: Per Otteskog, Vice President Investor Relations Direct telephone: +46-8-608 6018 Mobile telephone: +46-70-632 7527 Background Karo Bio has operations in Sweden and the United States. The Company employs 130 people. Karo Bio has been listed on the Stockholm stock exchange (Reuters: KARO.ST) since 1998 and maintains a leading position in the field of drug discovery focused upon nuclear receptors. Nuclear receptors are validated drug targets for a number of clinical indications and the Company uses proprietary technologies for the development of novel and improved therapies for major markets. Karo Bio has 250 patent cases including 100 granted patents. Karo Bio has drug discovery programs in several therapeutic areas including men and women's health care, metabolic disorders such as obesity, cardiovascular disease, diabetes, dermatology and ophthalmology. Karo Bio collaborates with major pharmaceutical companies for development of products and marketing. In these partnerships Karo Bio receives upfront payments, R&D funding, milestone payments as well as royalties on net sales when products reach the market. Karo Bio has strategic pharmaceutical drug discovery partnerships with Abbott Laboratories, American Home Products, Bristol-Myers Squibb, Merck & Co., and Aventis. ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2001/10/09/20011009BIT00030/bit0002.doc http://www.waymaker.net/bitonline/2001/10/09/20011009BIT00030/bit0002.pdf