Yuhan's disc treatment gets nod for Phase 3 trials
YH14618, a degenerative disc disease treatment candidate that was licensed by Yuhan to New York-based Spine Biopharma, won approval to start Phase 3 clinical trials in the United States, the Korean company said Monday.
Under the green light from the U.S. Food and Drug Administration, Spine Biopharma will begin trials in June, with the goal of concluding in the first half of 2024.
Yuhan acquired the drug candidate from Konex-listed Ensol Biosciences in 2009. It was able to produce meaningful results confirming the candidate’s safety in Phase 1 and 2 clinical trials but failed to prove its effectiveness compared to a placebo.
In 2018, Yuhan signed a deal with Spine Biopharma for the transfer of technology related to the drug candidate. Yuhan would receive royalties on any future sales of the treatment.
Under the deal, Spine Biopharma holds exclusive rights to market the treatment in foreign countries, while Yuhan maintains the rights to market it in Korea.
BY SARAH CHEA [firstname.lastname@example.org]