Asieris Pharmaceuticals, a global biopharmaceutical company, has signed 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 U.S. for the independently developed APL-1202 (nitroxoline), subject to evaluation by CDC experts, to be used for treating Free-living Amoebae (FLA) infections.

Infections by free-living amebae (FLA) like Acanthamoeba, Balamuthia mandrillaris, and Naegleria fowleri are rare but often fatal (>90%), particularly in cases of amoebic meningoencephalitis. Treatment options are limited, with no FDA-approved products for FLA infections in the 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. 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.

“We are grateful for this opportunity to collaborate with the CDC, and this agreement enables new treatment options for FLA patients in the U.S.,” stated Ms. Joanna Zhang, Chief Medical Officer of Asieris Pharmaceuticals. “We look forward to collaborating closely with the CDC in the future, sharing clinical experiences of treating FLA infections with APL-1202 to meet the unmet needs of patients. We will continue to uphold our company’s mission of delivering innovative treatments to patients.”

In June 2024, a separate Investigational New Drug (IND) application for APL-1202 for the treatment of FLA was approved by China’s National Medical Products Administration (NMPA) to ensure clinical drug supply for domestic patients in China.