Asieris and CDC Sign Investigational Product Supply Agreement for APL-1202 in Free-Living Amoeba Infections Treatment under Expanded Access Investigational New Drug Program

SHANGHAI, Jan. 6, 2025 /PRNewswire/ -- 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.

"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."

Since 2021, FDA has granted single-patient emergency-IND requests (e-IND) for APL-1202 as an investigational drug for treatment of Balamuthia mandrillaris and Acanthamoeba infections. Two patients who received this treatment in the U.S. have fully recovered from their infections.

On June 24, 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.

About Asieris

Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve patient's dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.

The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.

Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.