Medivir Designates MIV-710 A Candidate Drug (CD) For Osteoporosis And Osteoarthritis

Medivir is developing selective cathepsin K inhibitors for the treatment of osteoporosis and osteoarthritis. Medivir has now designated a highly active and selective small molecule inhibitor of cathepsin K, MIV-710, as Candidate Drug (CD).



MIV-710 shows very pronounced efficacy, based on biomarkers for osteoporosis in preclinical models, with a long duration of effect after once daily oral dosing.



MIV-710 dose-dependently attenuates the break down of bone, the hallmark of osteoporosis, whilst maintaining the beneficial bone formation. MIV-710 is expected to be dosed conveniently only once daily as a tablet and at low doses, due it's favorable potency and pharmacokinetic properties.



Scientific background A selective inhibitor of the cathepsin K enzyme is believed to play a central role in osteoclastic bone resorption, particularly in the degradation of the protein component of bone. Inhibition of cathepsin K is a novel approach to the treatment of osteoporosis that differs from those of currently approved treatments. By developing a drug that attenuates this activity, excessive bone degradation, as occurs in e.g. patients with osteoporosis, can be normalized and the imbalance in bone turnover can be restored. In disease models Medivir has shown that the pathological resorption (break down) of bone can be dose dependently suppressed by blocking cathepsin K activity. MIV-710 also demonstrates potent effects in a human cell-based model of bone resorption.



Therapeutic opportunities The main clinical indication for MIV-710 is osteoporosis but included are also RA (rheumatoid arthritis), OA (osteoarthritis) and bone metastasis. Osteoporosis (brittle bones) arises from an imbalance between skeletal formation and resorption where the equilibrium is skewed towards excessive bone loss. There is a large unmet medical need for new and improved treatments that can regulate and suppress the progression of pathological bone erosion. Osteoporosis is the second largest health problem in the world and a major cause of death, disability and medical expenditure. The presently dominating treatment principles are bisphosphonates and oestrogen receptor modulators.



"We are extremely pleased to have developed a new CD in the cathepsin K program showing these highly competitive and advantageous properties. Medivir has previously shown proof-of-principle in a phase I clinical trial with it's earlier cathepsin K inhibitor MIV-701. The very favorable efficacy and expected convenient low dosing makes MIV-710 a strong complement to the broad Medivir cathepsin K program. This is yet another clear sign of Medivir's productivity and competence in the development of efficacious orally active protease inhibiting drugs", comments Medivir VP Discovery Research, Professor Bertil Samuelsson.



Next step



Medivir is now in a strong position to move into outlicensing discussions for the cathepsin K program including MIV-710 and MIV-701 which both have the potential to become a first-in-class treatment option in this important disease area.



About osteoporosis



Osteoporosis is a big public health problem affecting more than 75 million people in the U.S., Europe, South America and Japan alone. It is a disease in which the bone mineral density and strength of bone are reduced increasing the risk of bone fracture as bones become more porous and fragile. The most common fractures associated with osteoporosis occur at the hip, spine and wrist and the risk of having an osteoporosis-related fracture increases with age. One in three women over age 50 will experience an osteoporotic fracture, as will one in five men. According to the International Osteoporosis Foundation (IOF), the worldwide incidence of hip fracture is approximately 1.6 million each year, and by 2050 this number could reach between 4.5 million and 6.3 million.



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