Shanghai, China, December 24, 2023 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced recently that its subsidiary, MetCura Pharmaceuticals AUS Pty Ltd, has received approval to conduct a Phase I clinical trial of APL-2301 (formerly known as ASN-1733; marketed as MET-102), used for the treatment of Acinetobacter baumannii infections, was approved for Phase I clinical trials in Australia.

The planned clinical trial in Australia will be the first-in-human Phase I trial for APL-2301. It aims to evaluate the safety, tolerability, pharmacokinetic characteristics of single and multiple doses of APL-2301, as well as the effect of drug-food interactions on its absorption and systemic exposure in healthy adult subjects.

Acinetobacter baumannii is a Gram-negative, opportunistic pathogen that primarily infects among immunocompromised hospitalized patients, often leading to severe pneumonia and bloodstream infections. It also causes other infections, such as the urinary tract and skin infections. Acinetobacter baumannii possesses the ability to rapidly acquire and disseminate drug resistance. Carbapenem-resistant Acinetobacter baumannii (CRAB) is considered as the top of the Critical Priority Pathogens by the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC), posing a global public health threat. It has been reported that there are approximately 1,000,000 global infections caused by Acinetobacter baumannii, with CRAB accounting for approximately 500,000 cases (around 75,000 cases in developed countries)¹. The resistance rate of CRAB in China is over 50%, and in some provinces, it can reach over 70%, while it is around 40% in Europe and the United States. The mortality rate associated with CRAB infections can range from 30% to 70%. Preclinical research data has shown that APL-2301 exhibits good antimicrobial activity against various clinical isolated Acinetobacter baumannii, particularly against CRAB.

Dr. Wu Hong, Chief Development Officer of Asieris Pharmaceuticals, stated, “We are pleased to receive approval for the Phase I clinical trial of APL-2301 in Australia. APL-2301 is a novel antibacterial drug developed by our company with a new mechanism of action, specifically for the treatment of Acinetobacter baumannii infections. Currently, there are limited options for effective treatment of CRAB infections, often requiring combination therapy. Preclinical research data has demonstrated that APL-2301 exhibits good activity against various clinical isolates of Acinetobacter baumannii, particularly against CRAB. The development of APL-2301 holds promise for providing a new treatment option for patients with Acinetobacter baumannii infections.”

Dr. Deng Yijun, Chief Scientific Officer and Co-founder of MetCura, said, “We are delighted that APL-2301 has been granted approval for Phase I clinical trial in Australia for the treatment of Acinetobacter baumannii infections. Patient with infections caused by CRAB has very limited treatment options, which  result in high mortality rates. APL-2301 is developed to address this high unmet medical need. MetCura commits to advance the clinical development of this promising antibiotic candidate.”

1.Nat.Rev.Drug Discov.2013,12,963.

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.

About MetCura

MetCura is the anti-infection innovative drug research and development platform under Asieris Pharmaceuticals, devoted to the development of a large variety of upgraded platforms for the treatment of community infections and filling the gaps in the iteration of macrolide antibiotics. At the same time, it develops a platform for novel mechanisms of action of metal chelators to explore innovative drugs for the treatment of viral infections and severe bacterial infections in hospitals.

Source:- Asieris