Samil Pharmaceutical said on the 7th that Lorecivivint, a new drug candidate for treating knee osteoarthritis for which it holds the exclusive distribution rights in Korea, recently completed the U.S. Food and Drug Administration (FDA) new drug application (NDA) process.
The drug was developed by Biosplice Therapeutics, a biotech company headquartered in San Diego.
The company has focused on developing a first-in-class (world's first innovative new drug) small molecule inhibitor targeting CLD/DYRK kinase. CLD and DYRK kinases are intracellular signaling protein enzymes that regulate chondrocyte degeneration and inflammatory responses. Small molecule inhibitors are compounds with small molecular size that directly block the activity of protein enzymes that cause disease.
Lorecivivint was developed as a suspension formulation administered as an intra-articular injection 1–2 times a year. The company said, "Across a total of 11 clinical trials, we confirmed a very favorable safety profile and consistently demonstrated improvements in pain and function."
According to the company, a phase 3 trial conducted over two years confirmed improvement in medial joint space width (JSW) as measured by X-ray. This is a key indicator that reflects cartilage loss, meaning Lorecivivint has the potential to be a treatment in the knee osteoarthritis field that can slow disease progression itself, the company said.
In the cohort that received Lorecivivint, pain improved versus placebo at month 6, and both pain and function showed statistically significant improvement at month 12. Structural changes were also positive. In the cohort that received two doses of Lorecivivint at one-year intervals, medial joint space width was maintained, and in the placebo group—whose joint space had narrowed after one placebo dose—an additional single dose of Lorecivivint was associated with a trend toward increased joint space.
Erich Hosli, CEO of Biosplice, said, "We are pleased to have filed for U.S. new drug approval after more than 10 years of clinical development," adding, "We hope to dramatically improve the treatment journey for osteoarthritis patients in pain through a new therapeutic option that is safe, effective, and can slow structural progression."