MEDIVIR FILES CLINICAL TRIAL APPLICATION TO START PHASE I WITH MIV-701.
Medivir has filed an application with a European regulatory authority to commence phase I clinical trials with MIV-701, an inhibitor of cathepsin K. The trials are expected to start in Q1/2007.
Inappropriately high activity of cathepsin K is thought to be a factor behind diseases such as osteoporosis, osteoarthritis, rheumatoid arthritis, Paget’s disease and certain tumours causing bone metastases. Selective inhibition of cathepsin K could become a new treatment principle for these diseases.
“There is an important need for new and effective drugs against these diseases”, says Dr Disa Böttiger, Head of Development Department/Project Director for the development of MIV-701. “Thus far no drug based on inhibition of cathepsin K has reached the market. Several large pharmaceuticals companies are also working with this treatment principle and there are early clinical studies showing positive results from inhibiting cathepsin K. Our compound MIV-701 is a very potent and selective inhibitor of cathepsin K and provides a marked reduction in biomarkers of bone degradation in several model systems”.
Compounds inhibiting cathepsin K are expected to decrease degradation of bone in osteoporosis, without inhibiting bone formation. This would be a great advantage compared to the drugs most used today, the various bisphosphonates which inhibit both bone degradation and bone formation. The market for osteoporosis treatment is currently in excess of USD 9 billion annually and is considered likely to grow to USD 11 billion in 2008.
Cathepsin K inhibitors are also expected to be efficacious against arthritis conditions and skeletal metastases from malignant tumours. Arthritis is the most common disease of joints, and inhibition of cathepsin K offers a possibility to retard the degradation of joint cartilage. The market for arthritis drugs is estimated to be USD 4.5 billion annually in the US. Treatment of arthritis is currently limited to pain relief and antinflammatory drugs which do not prevent cartilage degradation. The market for drugs against tumour metastases with bone affinity is currently USD 1.5 billion per year and this is also an area with a great unsatisfied medical need
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