Lorecivivint delays osteoarthritis structural progression in long-term extension study
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Repeat injections of the Wnt pathway inhibitor lorecivivint appears to have slowed the decline of medial joint space width in knee osteoarthritis, according to interim results from a long-term extension trial released by Biosplice.
“We believe these unique data highlight lorecivivint’s promise to potentially provide structural benefit to the millions of patients suffering from osteoarthritis,” Yusuf Yazici, MD, chief medical officer at Biosplice, said in a company press release announcing the interim results.
The phase-3 long-term extension trial, called OA-07, included patients who successfully completed a previous 12-month study. The study’s objective was to measure the performance of lorecivivint (SM04690, Biosplice) in patients with knee OA over multiple years and injections. Patients and involved providers were blinded during the first year of the study while participants received annual injections.
According to Biosplice, data from the first year of the trial demonstrated clinically significant improvement in medial joint space width (mJSW). In patients receiving lorecivivint injections, this resulted in an effect size of 0.13 mm in mJSW, compared with patients who received placebo, read the release. Additionally, OA-07 data demonstrated a significant improvement in WOMAC Pain and robust trends in Pain Numeric Rating Scale scores, as well as WOMAC function in all subjects.
During the second year of the trial, patients who were originally randomized to receive placebo began receiving lorecivivint. Among those who completed their second annual OA-07 visit, and who previously had received placebo, the initiation of lorecivivint appears to have delayed reductions in mJSW, according to Biosplice.
Additionally, the drug appears to be safe, as repeated injections resulted in no safety signals, the release said.
“These latest interim results from OA-07 build upon our robust body of existing evidence, suggesting that repeat injections of LOR could provide patients and physicians with both structure-modifying and symptomatic benefits,” Yazici said in the release.
Biosplice has also initiated OA-21, a phase 3 trial investigating lorecivivint in patients with OA. The primary endpoint of OA-21 will be Pain Numeric Rating Scale scores at 12 weeks, the release said.
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