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 investigational drug supply agreement Expanded Access Investigational New Drug (IND). within: The program with Centers for Disease Control and Prevention (C.D.C) in United States for independently developed APL-1202 (nitroxoline) subject to evaluation by C.D.C experts to be used in the treatment of free-living amoeba (FLA) infections.
Infections caused by free-living amoebae (FLA) such as Acanthamoeba species (spp.), Balamuthia mandrillarisand: Naegleria fowleriare rare. However, FLA infections are often fatal (> 90%), especially when they cause amebic meningoencephalitis. Treatment options for FLA infections are limited, and there is currently no agency-approved treatment United States Food and Drug Administration (FDA) specifically for the treatment of FLA infections United States (USA:) An extended access IND application has been filed C.D.C FDA to grant 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 United States. FLA patients will receive treatment with APL-1202 under special conditions.After the agreement, Asieris immediately arranged for a drug transfer to ensure the supply of clinical drugs for FLA patients.
“We are grateful for this opportunity of cooperation C.D.Cand this agreement enables new treatment options for FLA patients USA:“- announced Ms. Joanna Zhangboss Medical (TASE:) Officer Asieris Pharmaceuticals. “We look forward to close cooperation C.D.C In the future, we will share the clinical experience of treating FLA infections with APL-1202 to address unmet patient needs. We will continue to uphold our company’s mission to deliver innovative treatments to patients.”
Beginning in 2021, the FDA is granting single-patient emergency IND requests (e-IND) for APL-1202 as an investigational drug for treatment. Balamuthia mandrillaris and: Acanthamoeba infections. Two patients who received this treatment USA: fully recovered from infections.
On June 24, 2024An individual investigational new drug (IND) application for APL-1202 for the treatment of FLA has been approved of China National Medical Products Administration (NMPA) to ensure the supply of clinical drugs for inpatients China.
About Asieris
Asieris Pharmaceuticals(688176.SH), was established March 2010is a global biopharmaceutical company specializing in the discovery, development and commercialization of innovative medicines for the treatment of genitourinary tumors. We strive to improve human health while preserving patient dignity. We aim to be a global pharmaceutical leader that integrates R&D manufacturing and commercialization is our focus as we provide best-in-class integrated diagnostic and treatment solutions for patients. China and around the world.
The company develops its own R&D platform and core technologies, explores new mechanisms of action, and efficiently screens and evaluates drug candidates. With a well-established in-house R&D system and global drug development expertise, Asieris is committed to launching first-in-class drugs and other innovative products. to address the vast unmet needs in its focus.
Asieris is also expanding its genitourinary disease pipeline through proprietary research and development and strategic partnerships, while keeping a close eye on the latest technologies and therapeutics. We aim to build an outstanding portfolio spanning diagnostics and treatments to benefit more patients China and globally.
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