Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib clinical study for its drug candidate APL1401. The study, which is set to be a randomized, double-blind, global multi-center trial, will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of APL1401 in treating moderate to severe active ulcerative colitis (UC) in both the US and China.
APL-1401: A Novel Dopamine-Beta-Hydroxylase (DBH) Inhibitor
APL-1401 is an in-house developed dopamine-beta-hydroxylase (DBH) inhibitor that operates through a new mechanism of action. The drug has the potential to increase dopamine (DA) levels and reduce the concentration of norepinephrine (NE), thereby restoring intestinal immune homeostasis to normal conditions. This approach targets the unmet need for a cure for UC, a condition for which there is currently no definitive cure.
Implications for Ulcerative Colitis Treatment
The approval to proceed with the Phase Ib study marks a significant step forward in the development of APL1401 as a potential treatment for UC. The global trial will provide valuable data on the drug’s performance and help determine its viability as a therapeutic option for patients suffering from moderate to severe active UC.-Fineline Info & Tech
