Investigational Drug Shows Efficacy as Disease-Modifying Therapy for Knee Osteoarthritis

Medivir to present positive data at the annual meeting of the American College of Rheumatology.

Medivir recently announced that novel data from a phase 2a clinical trial of MIV-711 in patients with moderate knee osteoarthritis will be presented at the 2017 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals

Annual Meeting.

The abstract discusses how the investigational cathepsin K inhibitor may benefit patients with osteoarthritis. MIV-711 is being assessed as a potential therapy to slow or reverse the progression of osteoarthritis.

More than 30 million Americans have osteoarthritis and currently, there are no disease-modifying therapies indicated to treat the condition, only analgesics for day-to-day symptoms, according to a Medivir press release. Long-term analgesic use can result in gastrointestinal bleeding and opioid dependence, making disease-modifying therapies a critically unmet need, according to Medivir.

Included in the clinical trial were 244 patients with moderate knee osteoarthritis. The secondary endpoints analyzed the effect of MIV-711 on joint structure via MRI scan.

At 26 weeks, structural data showed that patients treated with MIV-711 100-mg and 200-mg had a significant reduction in medial femur bone area growth compared with placebo, according to Medivir.

The researchers also found that patients treated with MIV-711 had a reduced loss of medial femur cartilage thickness compared with placebo.

The investigators report that the primary endpoint of NRS pain score reduction was not statistically significant among the cohorts. However, the investigators noted that pain score for MIV-711 was observed across patient-reported outcomes, including symptom, function, and quality of life, according to the study.

The authors also noted that MIV-711 demonstrated acceptable safety and tolerability.

"The selection of the abstract setting out the results of the MIV-711-201 study as a late-breaking presentation at the ACR Annual Meeting highlights the level of importance of the clinical findings from this trial," said John Öhd, chief medical officer of Medivir. "The improvements in structural outcomes in patients after just 26 weeks treatment with MIV-711 represent a unique finding and offer the prospect that MIV-711 could be the first oral disease-modifying osteoarthritis drug. Although there was no statistically significant reduction in pain, it should be emphasized that the study duration required to fully realize symptom benefits expected from structure modification is unclear. It is however evident that further evaluation of MIV-711 in longer and larger osteoarthritis disease modification trials are now warranted.”