Asieris Pharmaceuticals (Stock Code: 688176.SH), a leading global biopharmaceutical company dedicated to advancing innovative therapies for genitourinary tumors and women’s health with significant unmet medical needs, announced the signing of an investigational drug supply agreement under the Expanded Access Investigational New Drug (IND) Program with the Centers for Disease Control and Prevention (CDC) in the United States for the independently developed APL-1202 (nitroxoline), subject to evaluation by CDC experts, to be used for treating Free-living Amoebae (FLA) infections.
Infections caused by free-living amebae (FLA), such as Acanthamoeba species (spp.), Balamuthia mandrillaris, and Naegleria fowleri, are rare. However, FLA infections are often fatal (> 90%), especially when they cause amoebic meningoencephalitis. Treatment options are limited for FLA infections, and currently, there is no product approved by the United States Food and Drug Administration (FDA) specifically for the treatment of FLA infections in the United States (U.S.). An expanded-access IND application was submitted by the CDC to FDA to provide APL-1202 for treatment of laboratory-confirmed or suspected non-keratitis infections caused by FLA including Acanthamoeba spp., B. mandrillaris, and N. fowleri.
Nitroxoline has not been approved by the FDA, and its use is therefore considered investigational in the United States. FLA patients will receive treatment with APL-1202 under specific conditions. Following the agreement, Asieris promptly arranged drug transportation to ensure clinical drug supply for FLA patients.
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