Phase III OA-7 long-term extension trial of lorecivivint shows safety and efficacy in knee osteoarthritis pain

Results from the study continue to support the potential efficacy of multiple injections of lorecivivint in delaying structural progression and providing symptomatic benefit.

OA-07 is a long-term extension trial, which enrolled patients who completed OA-11, a previous 12-month study. The primary efficacy objective of OA-07 is to measure the disease-modifying potential of lorecivivint over multiple years and injections. During the first year of the OA-07 study, patients and investigators remained blinded and patients received injections of lorecivivint on an annual basis, allowing Biosplice to capture both long-term and repeat-injection data for safety, efficacy and mJSW. Previously presented at the American Conference of Rheumatology Annual Meeting in November 2022, data for the first year of OA-07 show clinically significant improvement in medial joint space width (mJSW) relative to placebo, with an effect size of 0.13 mm in KL2 subjects. Moreover, OA-07 data demonstrate a significant improvement in WOMAC Pain and robust trends in Pain NRS (daily pain score) as well as WOMAC function in all subjects.

In the second year of the OA-07 trial, placebo subjects crossed-over to receiving lorecivivint, although all subjects remain blinded as to whether they had previously received lorecivivint or placebo. In subjects who have completed their second annual visit and who previously received lorecivivint in OA-11 and OA-07, there continues to be an increase in their mJSW versus baseline. These subjects have now received three injections of lorecivivint over three years. Among those subjects who have completed their second annual OA-07 visit and who previously had received placebo, the introduction of lorecivivint appears to have arrested their decline in mJSW. Consistent with the clinical program to date, lorecivivint continued to appear safe and well-tolerated in the recently completed studies, with no safety signals with repeat injections. The OA-21 phase III clinical trial is designed as a 16-week study with a primary endpoint of Pain NRS at 12 weeks. This study will further evaluate the impact of lorecivivint on knee osteoarthritis pain and function and has been designed to enroll the less structurally damaged patient population that has shown consistent responses across Biosplice’s phase II and phase III clinical trials.