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 explore the impact of drug-food interactions on its absorption and systemic exposure in healthy adult subjects.

Acinetobacter baumannii is a Gram-negative, opportunist pathogen that primarily infects critically ill patients, often leading to severe pneumonia and bloodstream infections. It also cause 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."