SHANGHAI, China I October 28, 2020 I Asieris Pharmaceuticals, a China-based biotech company specializing in the development and commercialization of new drugs for the treatment of genitourinary tumors and related diseases, today announced that Australian regulatory authorities have approved its Phase I clinical trial of APL-1501. The objective of this Phase I study is to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of APL-1501.

APL-1501, which is independently developed by the Prodrug Accurate Drug Delivery (PADD) platform of Asieris, is an oral sustained-release product based on APL-1202 and will be the second generation product of APL-1202 to support new clinical development globally. APL-1501 inherits the unique oral administration of APL-1202 and the druggability of APL-1501 is improved by the design of prodrug molecules. Based on these, APL-1501 can improve patient compliance by reducing medication frequency, combined with the sustained-release technology which can contribute to controlled drug release and lengthen the drug plasma exposure time. APL-1501 has better pharmacokinetic (PK) characteristics so that this product is expected to not only treat bladder cancer, but also for other diseases such as prostate cancer, urinary tract infection, etc. Since APL-1501 is a product developed by Asieris independently, a comprehensive global intellectual property rights strategy has been developed to provide strong support for product life cycle managment and global expansion.

APL-1202 is being developed as a new drug of Asieris for the treatment of non-muscle invasive bladder cancer (NMIBC). It is the first oral and reversible methionine aminopeptidase II type (MetAP2) inhibitor currently under Phase III clinical development in the world. APL-1202 finished patient enrollment in pivotal registration trial in China in 2019. APL-1202 also completed the Phase I clinical trial in the US. Currently, the standard treatment of NMIBC is a Trans-Urethral Resection of Bladder Tumor (TURBT). Because of a high tumor recurrence rate after TURBT, intravesical chemo- or immune-therapies are required after the procedure. At present, choice of second-line treatment for relapsed patients is very limited. A radical cystectomy is the standard treatment for recurring high-risk NMIBC patients. No oral drugs have been approved for NMIBC to date.

“The approval of APL-1501 clinical trial in Australia is another important milestone on the journey of Asieris’ international clinical development”, commented Dr. Kevin Pan, founder and CEO of Asieris. “As the second generation product of APL-1202, APL-1501 will bring better treatment choice to patients and reduce the pain and adverse reactions. Asieris will continue to adhere to the vision of ‘We strive for healthy and dignified lives’. We hope the innovative products will benefit more patients globally soon.”

About APL-1501 and APL-1202

APL-1501 is developed by Asieris from its PADD technology platform as the second generation product of APL-1202, which has better pharmacokinetic characteristics. Besides the treatment of NMIBC, the product is expected to enter more therapeutic fields for clinical development, such as prostate cancer, urinary tract infection, etc.

APL-1202 is being developed as a new drug of Asieris for the treatment of non-muscle invasive bladder cancer (NMIBC) and is the first oral and reversible methionine aminopeptidase II type (MetAP2) inhibitor currently under Phase III clinical development in the world. In preclinical studies, APL-1202 has demonstrated both anti-angiogenic and anti-tumor activities as well as a potential synergistic effect with anti-BCG or epirubicin. APL-1202 is currently under clinical investigation for multiple indications. The treatment regimen with APL-1202 is convenient and well-tolerated, without causing pain or injury to the urethra, and may help some high-risk patients avoid radical cystectomy.

About Asieris Pharmaceuticals

Asieris Pharmaceuticals was founded inside the ‘China Medical City’ located in the city of Taizhou, Jiangsu Province, PRC, in March 2010. Asieris is determined to become a leading pharmaceutical company driven by innovative technologies and products that focus on genitourinary tumors and related diseases. The company and its professional teams are located in Shanghai, Beijing, Taizhou, and the US, with their research and development center in Jinqiao District, Shanghai.

Asieris adheres to the growth model of proprietary R&D supplemented by in-licensing, to rapidly establish leadership in their focused fields with in-depth strategic plans. We create global values with our first-in-class innovative drugs with breakthrough potentials. Meanwhile, we have unique R&D platforms for anti-tumor and anti-microbial resistance drugs. In addition, we in-license late-development stage and marketed products for the Chinese market to enhance our pipeline and to quickly establish our leadership position in the domestic market.

Note: * APL-1501 has replaced the previous internal code name of APL-1301

SOURCE: Asieris Pharmaceuticals