Asieris Pharmaceuticals (SHA: 688176), a Chinese specialist in urogenital cancer, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate APL-1202 for the treatment of free-living amoebae (FLA) infections.
APL-1202, an oral MetAP2 inhibitor, is currently in a Phase III clinical study for the treatment of naive medium-risk non-muscle invasive bladder cancer (NMIBC) and a Phase II clinical study as an adjuvant therapy for muscle invasive bladder cancer (MIBC) in combination with tislelizumab.
The NMPA-approved multi-center, single-arm Phase II study is designed to evaluate the efficacy and safety of APL-1202 in treating FLA infections. Asieris aims to secure the clinical drug supply for FLA infection cases in China through this study. While the incidence rate of brain infections caused by FLA is extremely low, the mortality rate stands at a staggering 90%. In February 2023, the journal Science published a report detailing how APL-1202 saved the life of a male patient infected with a brain-eating amoeba parasite. Researchers at the University of California, San Francisco (UCSF) discovered that APL-1202 has a significantly stronger inhibitory effect on the amoeba parasite Paramecium compared to other anti-amoeba drugs.- Fineline.com
