SHANGHAI, January 6, 2025 /PRNewswire/ — Asieris Pharmaceuticals (Stock Code: 688176.SH), a leading global biopharmaceutical company dedicated to advancing medicines to improve genitourinary tumors and the health of women with unmet medical needs, announced the signing of a research agreement for the supply of drugs under the Expanded Access to Investigational New Drug (IND) Program and Centers for Disease Control and Prevention (The CDC) in a the United States because it was developed independently APL-1202 (nitroxoline), depending on the test by The CDC Specialists, to be used to treat Amoebae infections (FLA).
Infections caused by free-living amebae (FLA), such as Acanthamoeba species (spp.), Balamuthia mandrillarisand Naegleria fowleriare rare. However, FLA infection is often fatal (>90%), especially when it causes amoebic meningoencephalitis. Treatment options are limited for FLA infections, and currently, there are no approved products Food and Drug Administration in the United States (FDA) specifically for the treatment of FLA infection the United States (US). Extended access IND application 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 certain conditions. Following the agreement, Asieris quickly arranged the shipment of the drugs to ensure the supply of clinical drugs to FLA patients.
“We appreciate this opportunity to work with The CDCand this agreement creates a new treatment option for FLA patients in US,” said Ms. Joanna ZhangThe king Medical (TASE:) This officer Asieris Pharmaceuticals. “We look forward to working closely with The CDC in the future, sharing the clinical experience of treating FLA infection with APL-1202 to meet the unmet needs of patients. We will continue to support our company's mission to bring the best treatments to patients.”
As of 2021, the FDA has granted a single-patient emergency IND application (IND) for APL-1202 as an investigational drug for the treatment of Balamuthia mandrillaris and Acanthamoeba infection. Two patients who received this treatment at US they have fully recovered from their infection.
Open up June 24, 2024A separate Investigational New Drug (IND) application for APL-1202 for the treatment of FLA was accepted by. in China National Medical Products Administration (NMPA) to ensure the delivery of clinical drugs to local patients in China.
About Asieris
Asieris Pharmaceuticals(688176.SH), was established in March 2010is a global biopharma company specializing in the discovery, development and commercialization of new 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 the patient. We aim to be a global pharma leader integrating R&D, manufacturing and marketing in our target areas, as we provide the best integrated diagnostics and therapeutic solutions for advanced patients. in China and around the world.
The company is developing its proprietary R&D platform and leading technologies, exploring new ways of doing things, and effectively 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 medicines and other innovative products to address large unmet needs in its focus areas.
Asieris is also improving its genitourinary disease pipeline through proprietary R&D and strategic partnerships, while closely following technology and clinical development. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach to product planning and life cycle management. We aim to establish an excellent portfolio that includes diagnosis and treatment in an effort to help more patients in China and around the world.
