Shanghai, China, June 24, 2024 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases, announced that its Investigational New Drug (IND) for investigational drug APL-1202 (nitroxoline) has been approved for the treatment of Free-living Amoebae (FLA) infections by Center for Drug Evaluation (CDE)，part of the National Medical Products Administration (NMPA).
This study is a multicenter, single-arm Phase II clinical trial aiming to evaluate the efficacy and safety of APL-1202 for the treatment of FLA infections. There’s no treatment guidelines and expert consensus for FLA infections worldwide, particularly for FLA-induced brain infections, which have a low incidence rate but a high mortality rate as 90%. Existing potentially effective treatment options are based on limited case reports without established standard of care.
In February 2023, Science magazine published a story about APL-1202 saving a man’s life by University of California, San Francisco (UCSF) from Balamuthia mandrillaris Granulomatous Amebic Encephalitis (GAE), one kind of FLA infections that is an extremely rare central nervous system infection caused by the Balamuthia mandrillaris amoebae. UCSF and a research team from the Chan Zuckerberg Biohub screened thousands of compounds and discovered that compared with other anti-amebic drugs, nitroxoline has a stronger inhibitory effect on Balamuthia mandrillaris amoebae. The UCSF medical team requested urgent assistance from Asieris, and the company promptly delivered APL-1202 through US expanded access program.
Since 2021, the U.S. Food and Drug Administration (FDA) has granted a total of two single-patient emergency-IND requests (e-IND) for APL-1202 as an investigational drug for treatment of Balamuthia mandrillaris GAE. The patients are receiving treatments at UCSF and UT Southwestern Medical Center, respectively, and are both recovering well.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, stated, “We always put patients first and will continue to focus on their unmet needs. Currently, patients and families suffering from free-living amoebiasis infection are confronted with significant challenges due to the scarcity of approved medications and standard of care. Through this research, we aim to secure clinical drug access for patients in China and collaborate with experts and patients to provide them with the opportunity for a more effective treatment. Ultimately, our goal is to bring positive changes to the lives of patients and their families, fulfilling our social responsibility as a corporate citizen.”
There are no further development plans for APL-1202 in FLA at this moment of time. APL-1202 has an ongoing Phase III clinical trials as a monotherapy for untreated intermediate-risk non-muscle invasive bladder cancer (NMIBC). Additionally, a Phase II clinical trial is currently underway to evaluate the combination of oral APL-1202 with tislelizumab as a neoadjuvant treatment for muscle-invasive bladder cancer (MIBC).
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.
