May 3, 2018

MIV-711 Reduces Bone, Cartilage Disease Progression in Patients With Knee Osteoarthritis

By Chris Berrie

LIVERPOOL, United Kingdom -- May 3, 2018 -- MIV-711 significantly reduces bone and cartilage disease progression in patients with knee osteoarthritis, according to a study presented here on April 27 at the 2018 Osteoarthritis Research Society International (OARSI) World Congress.

However, the primary endpoint for knee pain was not reached, most likely due to the short duration of the study, according to Philip G. Conaghan, MD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom.

Currently, there are no approved disease-modifying drugs (DMOADs) for patients with osteoarthritis, as current treatments target only the symptoms, rather than the progressive deterioration of joint structure. There is thus the urgent need for development of new DMOADs.

MIV-711, a potent, selective and reversible inhibitor of cathepsin K, which is a cysteine protease involved in bone resorption and cartilage degradation.

To assess the efficacy and safety of MIV-711, the researchers randomised patients with knee OA to receive placebo (n = 77) or MIV-711 100 mg (n = 82) or 200 mg (n = 81) once daily for 26 weeks.

All patients had pain on a numeric rating scale (NRS, 1-10) of ≥4, but <10 and were allowed to remain on their usual analgesic medication.

Clinical (pain, function, quality of life) and safety data were assessed and an MRI was performed at baseline and at week 26.

The primary outcome of change in NRS pain score was not reached.

However, the key secondary endpoint of change in MRI bone area (medial femur) was significant for the 100 mg dose of MIV-711 and the 200 mg dose (P = .002, P = .004, respectively).

“What we see here is a slowing in loss of bone,” said Dr. Canaghan.

Loss of medial femur cartilage thickness was significantly less with MIV-711 100 mg (P = .023), although only a trend with the 200 mg dose (P = .125).

MIV-711 also showed target engagement with rapid and sustained suppression of type 1 and type 2 collagenase C-telopeptidase (P< .0001 for both doses vs placebo).

Skin disorders and infections were more common in the MIV-711 groups versus placebo. There were 9 serious adverse events in 6 patients, but none were deemed related to the study drug.

“The overall data, together with what we’ve seen for these structural effects, do warrant this drug moving forwards into further trials,” said Dr. Conaghan.

Funding for this study was provided by Medivir.

[Presentation title: Six Months’ Treatment With MIV-711, a Novel Cathepsin K Inhibitor Induces Osteoarthritis Structure Modification: Results From a Randomized Double-Blind Placebo-Controlled Phase IIA Trial. Abstract 29]
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