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Medivir AB Announces Positive Results from Phase Ia Study with MIV-711 for Treatment of Skeletal Disorders


Tuesday, 21 May 2013 07:00am EDT 

Medivir AB announced that data from a first in man study on the investigational cathepsin K inhibitor MIV-711 for the treatment of osteoarthritis and osteoporosis was presented on May 21, 2013 at the European Calcified Tissue Society (ECTS) Annual Meeting in Lisbon, Portugal. A double-blind, placebo-controlled, randomized study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of 20 to 600 mg of MIV-711 in healthy male and female subjects (N=27). MIV-711 was given as an oral capsule and at each dosing occasion, seven subjects received MIV-711 and two received placebo. The results show that single doses of MIV-711 were safe and well tolerated in healthy subjects and displayed linear pharmacokinetics over the investigated dose range (20 – 600 mg). Serum levels of the bone resorption biomarker CTX-I were suppressed in a dose dependent manner) with up to 79% reduction at 24 hours after dose. 

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30 Oct 2014