Asieris and CDC sign investigational product supply agreement for APL-1202 in the treatment of free-living amoeba infections under an expanded access investigational new drug program

SHANGHAI, January 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 a drug supply agreement investigations under the Expanded Access Investigational New Drug (IND) The program with the Centers for Disease Control and Prevention (CDC) in the United States for the independently developed APL-1202 (nitroxoline), undergoing evaluation by CDC experts, to be used to treat free-living Amoeba (FLA) infections.

Infections caused by free-living amoebas (FLA), such as Acanthamoeba species (spp.), Balamuthia mandrillarisand Naegleria fowlerithey are rare. However, FLA infections are often fatal (>90%), especially when they cause amebic 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 (US). An extended access IND application was submitted by the CDC to the FDA to provide APL-1202 for the treatment of laboratory-confirmed or suspected non-keratitis infections caused by FLA including Acanthamoeba spp., B. mandrillarisand N. fowleri.

Nitroxoline has not been approved by the FDA, and its use is therefore considered investigational the United States. FLA patients will receive treatment with APL-1202 under specific conditions. After the agreement, Asieris promptly organized drug transport to ensure the supply of clinical drugs for FLA patients.

“We are grateful for this opportunity to collaborate with the CDCand this agreement allows new treatment options for FLA patients in the US“said Ms. Joanna ZhangChief Medical (TASE:) Officer of Asieris Pharmaceuticals. “We look forward to collaborating closely with the CDC in the future, share the 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 providing innovative treatments to patients.”

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

Hon June 24, 2024a separate Investigational New Drug (IND) application for APL-1202 for the treatment of FLA was approved by of China National Medical Products Administration (NMPA) to ensure the supply of clinical drugs for domestic patients in China.

About Asieris

Asieris Pharmaceuticals(688176.SH), founded in March 2010is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve the dignity of patients. We aim to become a global pharmaceutical leader integrating R&D, manufacturing and marketing in our focus areas as we provide the best integrated diagnosis and treatment solutions for patients in China and throughout the world.

The company has developed its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently analyzing 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-class drugs and other innovative products to address huge unmet needs in its focus areas.

Asieris is also strengthening its pipeline for genitourinary diseases through proprietary R&D and strategic partnerships, while closely pursuing cutting-edge technologies and therapies. The company is committed to discovering and identifying unmet clinical needs, and takes a forward-thinking approach to product planning and life cycle management. We aim to establish an exceptional portfolio covering diagnosis and treatment in an attempt to benefit more patients China and in the world.