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 an expanded access investigational new drug (IND) supply contract. Centers for Disease Control and Prevention (CDC) in United States for independently developed APL-1202 (nitroxoline), subject to evaluation by CDC specialist, which will be used to treat infections with free-living amoebas (FLA).
Infections caused by free-living amoebae (FLA), such as Acanthamoeba species (spp.), Balamuthia mandrillarisand Naegleria fowlerithey are rare. However, FLA infections are often fatal (> 90%), especially when they cause amoebic meningoencephalitis. Treatment options are limited for FLA infections and there is currently no approved product United States Food and Drug Administration (FDA) specifically for the treatment of FLA infections in the United States (OUR). He submitted an application for IND with extended access CDC 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.
Nitroxolin has not been approved by the FDA, so its use is therefore considered investigational United States. Patients with FLA will receive APL-1202 treatment under certain conditions. After the agreement, Asieris immediately organized the transport of drugs to ensure the clinical supply of drugs for FLA patients.
“We are grateful for this opportunity to cooperate with CDCand this agreement enables new treatment options for patients with FLA in OUR“, said Mrs. Joanna Zhangchief Medical (TASE:) Clerk Asieris Pharmaceuticals. “We look forward to close cooperation with CDC in the future, sharing clinical experiences of treating FLA infections with APL-1202 to address unmet patient needs. We will continue to support our company’s mission to provide innovative treatments to patients.”
Beginning in 2021, FDA approves single-patient emergency IND applications (e-IND) for APL-1202 as an investigational treatment drug Balamuthia mandrillaris and Acanthamoeba infections. Two patients who received this treatment in OUR fully recovered from their infections.
On June 24, 2024a separate investigational new drug (IND) application for APL-1202 for the treatment of FLA has been approved by Chinese National Medical Products Administration (NMPA) to ensure the clinical supply of drugs for domestic patients in the China.
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010is a global biopharma company specializing in the discovery, development and commercialization of innovative medicines for the treatment of genitourinary tumors and other related diseases. We strive to improve people’s health in order to preserve the dignity of patients. We aim to become a global pharmaceutical leader that integrates research and development, manufacturing and commercialization in our focus areas, as we provide the best integrated solutions for the diagnosis and treatment of patients in China and around the world.
The company has been developing its proprietary R&D platform and underlying 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 enormous unmet needs in its focus areas.
Asieris is also advancing its genitourinary disease offering through proprietary research and development and strategic partnerships, while closely monitoring cutting-edge technologies and therapies. The company strives to discover and identify unmet clinical needs and adopts a forward-looking approach to product planning and lifecycle management. We aim to establish an outstanding portfolio covering diagnosis and treatment in an attempt to benefit more patients China and globally.
