Osteoarthritis is the most common form of joint disease and affects some 30 million people in the US alone1) and an estimated 240 million people worldwide. MIV-711 has the potential of becoming the first drug to slow, stop or even reverse the progression of osteoarthritis.
Up to 40 percent of the population over 65 suffer from osteoarthritis (OA), characterized by pain and varying degrees of inflammation in one or more joints, mainly knees, hips and hands. Osteoarthritis in weight-bearing joints, like knees and hips, induces an increasing level of pain and decreased mobility for the patient, and may eventually result in joint replacement surgery.
Drugs capable of slowing, stopping or even reversing the progression of the disease are referred to as Disease Modifying Osteoarthritis Drugs. There is currently no such therapy approved for osteoarthritis and current treatments affect only day to day symptoms without affecting degenerative changes in the diseased joint.1) Standard of care is based on changes in life style and the use of analgesics. The long-term use of analgesics by osteoarthritis patients is associated with an increased risk of side effects such as gastrointestinal bleeding and opioid dependency.
Recent scientific work suggests that two processes – increased bone turnover and cartilage degradation – are involved in the development and progression of OA. Treatments that target both bone resorption and cartilage degradation may have an improved chance to demonstrate a clinical effect.
Through its targeting of both bone resorption and cartilage degradation MIV-711 has a unique potential to be the first disease-modifying treatment for OA. It is administered orally once daily, making it convenient for patients.
Cathepsin K is a protease that breaks down collagen, a protein that plays an important role in the structural integrity of both bone and cartilage. Medivir’s research in preclinical models has demonstrated that inhibition of cathepsin K can reduce the rate of joint destruction of osteoarthritis, and these findings have now been supported in clinical studies.
Medivir’s phase II clinical program for MIV-711 was initiated in January 2016. The first part was the MIV-711-201 study, evaluating six months of treatment with two doses of MIV-711 in patients with moderate knee OA. Positive top-line results were released in September 2017. This was the first time that data demonstrated clinical benefits on both joint bone and cartilage in osteoarthritis patients after only six months of treatment.
The objective of the ongoing extension study MIV-711-202, for patients who have completed six months of treatment in MIV-711-201, is to evaluate safety, tolerability and efficacy of an additional 6-month treatment with MIV-711. Headline data from the extension study is expected during the first half of 2018.
In August 2017, the US FDA accepted Medivir’s IND application, which meant that clinical development of MIV-711 could begin in the US. MIV-711’s importance was further confirmed in October 2017 when the FDA granted Fast Track designation for MIV-711 as a disease-modifying agent for osteoarthritis.
Unmet medical need
No treatment with disease-modifying properties is available for osteoarthritis.
New Guidelines from FDA open up for structural endpoint for the development of drugs targeting Osteoarthritis.
“The finding that MIV-711
slows the degenerative
changes on both bone and
cartilage in knees affected
by OA is an enormously
Professor of Musculosceletal Medicine
University of Leeds, UK
Lead investigator on the MIV-711-201 study