MIV-711

About 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.

1. https://www.oarsi.org/sites/default/files/docs/2016/oarsi_white_paper_oa_serious_disease_121416_1.pdf

Benefits on both bone and cartilage

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.

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.

Publications

The-potential-clinical-relevance-of-imaging-biomarker-data-from-short-term-interventional-trials-in-osteoarthritis

The selective cathepsin K inhibitor MIV‑711 attenuates joint pathology in experimental animal models of osteoarthritis

MIV-711, a novel cathepsin K inhibitor demonstrates evidence of osteoarthritis structure modification