Yuhan Corp. said that its U.S. partner Spine Biopharma has received approval from the U.S. Food and Drug Administration for the phase 3 clinical trial of YH14618, a degenerative disc treatment candidate.

Spine Biopharma plans to start trials in June and obtain results by the first half of 2024.

YH14618 is a peptide drug, which Yuhan initially licensed from Ensol Bio in 2009 and confirmed its efficacy and safety through a clinical trial conducted in Korea. However, during a phase 2b clinical trial, the treatment failed to show statistically significant results in the drug group compared to the placebo group.

Therefore, Yuhan licensed the candidate to Spine Biopharma, a company specializing in spinal diseases, in 2018. Since then, it has completed an optimized phase 3 clinical trial plan for YH14618 through several meetings with the FDA.

The company also recently obtained an SMP (study may proceed) letter from the FDA, which allows the company to progress with the phase 3 trial without conducting a phase 2 clinical trial.

Although degenerative disc disease occurs in over 200 million patients worldwide every year, there is no fundamental treatment other than pain management. YH14618 prevents the progression of disc degeneration and potentially induces disc regeneration by binding to TGF-β1, highly expressed in degenerative discs, and modulating the down-signaling pathway, according to Yuhan.

Yuhan said developing a new approach would drastically change the current degenerative disc treatment market.