Samil Pharmaceutical Submits New Drug Application for Exclusive 'Lorecivivint' to U.S. FDA

On January 7, Samil Pharmaceutical announced that it has completed the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for 'Lorecivivint,' a new drug for the treatment of knee osteoarthritis, for which it holds exclusive domestic distribution rights.

'Lorecivivint' is a novel drug developed by Biosplice Therapeutics, a company based in San Diego, United States. Biosplice is a first-in-class drug development company focused on small molecule inhibitors targeting the CLD/DYRK kinase mechanism.

Among Biosplice's drug pipeline, 'Lorecivivint' is the first investigational drug with the potential to slow the progression of knee osteoarthritis. It is administered as an injection one to two times per year. Across a total of 11 clinical trials, it has demonstrated an excellent safety profile, as well as improvements in pain and joint function.

In particular, results from the phase 3 'OA-07' trial showed improvement in medial joint space width (JSW) as confirmed by X-ray imaging. The company explained that these clinical results support the potential of 'Lorecivivint' as the first disease-modifying osteoarthritis drug (DMOAD) in the field of knee osteoarthritis.

In the 'OA-07' trial, which was conducted over two years, patients who received 'Lorecivivint' showed improved pain compared to placebo at six months, and at 12 months, both pain and joint function were significantly improved compared to placebo. In addition to these symptom-relief effects, clinical results related to the structural progression of knee osteoarthritis were also confirmed. In the group that received two injections of 'Lorecivivint' at one-year intervals, the medial joint space width was maintained, while in the placebo group, which showed narrowing of the medial joint space after a single placebo injection, a single injection of 'Lorecivivint' subsequently led to an increase in medial joint space width.

Erich Horsley, CEO of Biosplice, stated, "After more than a decade of clinical trials, we are pleased to be the first to submit a U.S. approval application for a potential therapy that can slow the progression of knee osteoarthritis. As many knee osteoarthritis patients know, the current treatment journey for those diagnosed with osteoarthritis is painful and difficult. We hope that a new therapy that is safe, effective, and has the potential to slow structural progression will significantly improve the treatment journey for osteoarthritis patients."