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MIV-711 fails to meet pain endpoint in OA
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LIVERPOOL, England — Despite failing to meet the primary numeric rating scale pain endpoint, MIV-711, a novel cathepsin K inhibitor, demonstrated joint protection in patients with knee OA, according to findings presented here.
Philip Conaghan, MD, professor of Musculoskeletal Medicine, director of the Leeds Institute of Rheumatic and Musculoskeletal Medicine at the University of Leeds in the U.K., presented data on the effects of 6 months of treatment with MIV-711 on knee OA in terms of pain and function. Change in average knee pain at week 26 on the 11-point numeric rating scale (NRS) served as the primary endpoint, with a novel imaging outcome, 3D bone shape as key secondary outcome, and WOMAC, effect on 3D cartilage thickness, biomarkers, and safety serving as other secondary endpoints.
The analysis included 82 patients treated with 100 mg of the drug, 81 patients treated with 200 mg, and 77 who received placebo.
“In terms of NRS, we didn’t show a statistically significant difference between the three arms of the study,” Conaghan reported.
With regard to WOMAC, Conaghan suggested that the curves separated in the treatment groups compared with placebo. “But the 100-mg dose was getting more of a response than the 200-mg dose,” he said.
For function and stiffness, Conaghan suggested that a similar trend emerged. “We saw a consistent trend to reducing symptoms in the active arms,” he said.
Imaging outcomes demonstrated significant reduction in 3D bone shape change over the 6-month period in both the 100-mg (P = .002) and 200-mg (P = .004) groups, according to Conaghan. He added that the 100-mg dose also improved average cartilage thickness in the cMF (P = .023). “The study was not powered for a cartilage endpoint,” he said.
Biomarker outcomes showed suppression of CTX-I and CTX-2. “This is very good proof that this drug is on target and doing what we thought it would do,” Conaghan said, who noted no difference in terms of dose on biomarkers. “Probably, the 100-mg dose is doing all that we need to see.”
Conaghan said that safety data showed a “slight increase” in skin disorders and infections in the treatment arms, along with nine serious events that were deemed unrelated to treatment.
“The primary endpoint of knee pain was not met,” Conaghan concluded. “MRI measures demonstrated joint protection in only a 6-month study.” – by Rob Volansky
Reference:
Conaghan PG, et al. Abstract #29. Presented at: OARSI 2018 World Congress on Osteoarthritis; April 26-29, 2018; Liverpool, England.
Disclosure: Conaghan reports serving on the speakers' bureau for Kolon TissueGene and Samumed. He also reports serving on the advisory board for Abbvie, Centrexion, Flexion, Medivir, Novartis and ONO Pharma.