Asieris Pharmaceuticals and CDC Collaborate to Combat Free-Living Amoeba Infections with APL-1202

Shanghai, China – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases, has signed an investigational drug supply agreement with the Centers for Disease Control and Prevention (CDC) in the United States. This agreement, under the Expanded Access Investigational New Drug (IND) Program, enables the use of APL-1202 (nitroxoline) for treating Free-living Amoebae (FLA) infections, subject to CDC's expert evaluation.

FLA infections, caused by organisms such as Acanthamoeba spp., Balamuthia mandrillaris, and Naegleria fowleri, are relatively rare but often fatal, particularly when they lead to amoebic meningoencephalitis. The lack of approved medications and standard of care for FLA infections highlights the unmet medical need and the potential value of an effective treatment option like APL-1202.

The CDC's approval of APL-1202 under the Expanded Access IND Program allows for its use in treating FLA infections in the U.S., even though it has not been FDA-approved. This agreement provides an opportunity for APL-1202 to be used in treating FLA infections, even before it receives full FDA approval. The collaboration with the CDC also enhances Asieris Pharmaceuticals' reputation and credibility in the U.S. market, as it demonstrates the company's commitment to addressing unmet medical needs and working with regulatory authorities.

Asieris Pharmaceuticals has already received approval for the drug's Investigational New Drug (IND) application for the treatment of FLA infections from the National Medical Products Administration (NMPA) in China. Additionally, the company has signed an investigational drug supply agreement with the CDC in the United States for the use of APL-1202 in treating FLA infections under the Expanded Access IND Program. These developments indicate that there is potential interest and demand for APL-1202 as a treatment option for FLA infections, despite the relatively low incidence rate of these infections.

In conclusion, the collaboration between Asieris Pharmaceuticals and the CDC to combat FLA infections with APL-1202 highlights the company's commitment to addressing unmet medical needs and working with regulatory authorities. The agreement provides an opportunity for APL-1202 to be used in treating FLA infections in the U.S., even before it receives full FDA approval. The positive results from the expanded access program and any subsequent clinical trials can contribute to the drug's reputation and potential market acceptance in other regions.