Biosplice Therapeutics announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of lorecivivint (LOR) for the treatment of knee osteoarthritis (OA). The filing is based on data from 11 clinical trials, including the Phase 3 OA‑07 study, and represents what the company describes as the first potential disease‑modifying therapy for OA submitted to the FDA.
Lorecivivint is a small‑molecule suspension intended for injection into the knee joint 1–2 times per year that selectively inhibits DYRK1A and CLK2 kinases, mechanisms believed to reduce inflammatory processes and support cartilage‑protective pathways. In the OA‑07 study, patients treated with lorecivivint showed statistically significant improvements in pain and function at 6 and 12 months versus placebo, and improvements in medial joint space width (JSW)—a structural measure rarely seen in OA trials—over a two‑year period.
The company said that lorecivivint’s safety profile was comparable to placebo across more than 1,800 patients dosed, with minimal systemic exposure due to local intra‑articular administration. These results support the candidate’s potential to address both symptomatic and structural aspects of knee OA—a major unmet need for millions of patients in the United States and globally.
If approved, lorecivivint could become the first approved disease‑modifying osteoarthritis drug (DMOAD) for knee OA, offering clinicians and patients a novel therapeutic option beyond current symptomatic treatments. The company’s submission marks a significant milestone in its long‑term development programme for OA and positions lorecivivint for regulatory review in 2026.
