Zai Lab and Entasis Therapeutics announce positive key results of SUL-DUR Phase 3 clinical study ATTACK

Shanghai, October 19, 2021/PRNewswire/ - Zai Lab (NASDAQ: ZLAB; Hong Kong Stock Exchange: 9688) and its partner Entasis Therapeutics Holdings Inc.
(NASDAQ) (Code: ETTX) announced the ATTACK study-the key results of a global Phase 3 registered clinical study evaluating the safety and efficacy of SUL-DUR versus polymyxin in patients with Acinetobacter baumannii infection
.

In patients with carbapenem-resistant Acinetobacter infection (CRABC m-MITT [1] population of the study in Part A), SUL-DUR treatment reached the main study endpoint of 28-day all-cause mortality, indicating that there is more Compared with colistin, SUL-DUR treatment has statistically significant non-inferiority
.

Entasis CEO Manos Perros said: "SUL-DUR is the first investigational drug that has been proven effective against carbapenem-resistant Acinetobacter in a prospective, controlled clinical study
.

Dr.
Du Ying, founder, chairman and CEO of Zai Lab, said: "We are very pleased to see the positive results of this first prospective, controlled study of severe infections caused by carbapenem-resistant Acinetobacter.
As a result,
carbapenem-resistant Acinetobacter infection is one of the most serious bacterial infections, and safe and effective treatment options are limited
.

Dr.
Keith S.
Kaye, Dean of the School of Allergy, Immunology and Infectious Diseases of the Robert Wood Johnson School of Medicine, and Chairman of the ATTACK Research Data Security Regulatory Council, said: “Doctors and patients need new drugs for drug-resistant bacteria
.

The ATTACK study enrolled 207 patients in 95 clinical centers in 17 countries
.

Compared with polymyxin in the CRABC m-MITT population (n=125) in Part A, SUL-DUR reached the primary efficacy endpoint of 28-day all-cause mortality
.

A similar trend in favor of SUL-DUR was observed in all-cause mortality at 28 days and 14 days in all study populations evaluated so far

The difference in clinical cure rate observed in the clinical cure evaluation was statistically significant.
The SUL-DUR group was 61.
9%, while the polymyxin group was 40.
3% (95% CI: 2.
9, 40.
3)

In Part B, the 28-day all-cause mortality rate is 17.
9% (5/28), which is consistent with the results observed in Part A

Part A and Part B for the received at least one dose of medicament in a total of 205 patients were safety analysis
.

According to the RIFLE [2] classification standard, SUL-DUR meets the main safety goal, and its nephrotoxicity is statistically significantly reduced
.

The overall adverse events (AE) in the safe population was comparable between the treatment groups, 87.
9% (80/91) in the SUL-DUR group, and 94.
2% (81/86) in the part A in the polymyxin group , Part B is 89.
3% (25/28)

Drug-related adverse events in the SUL-DUR group were 12.
1% (11/91), while in the polymyxin group, part A was 30.
2% (26/86) and part B was 10.
7% (3/28)

[1].
Carbapenem-resistant Acinetobacter-Acinetobacter calcium acetate complex for microbiological adjustment of the intention-to-treat population

[2].
Danger-injury-failure-end-stage renal disease (measured by creatinine level or glomerular filtration rate)

About sulbactam-durlobactam (abbreviated as SUL-DUR)

SUL-DUR is an intravenous infusion drug in the research stage.
It is sulbactam (an intravenous infusion of β-lactam antibiotic) and durlobactam (a new type of broad-spectrum intravenous infusion of β-lactam) Enzyme inhibitors, or BLI) combination drugs
.

Zai Lab has the exclusive license to develop and commercialize SUL-DUR in Mainland China, Hong Kong, Taiwan, Macau, South Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, Philippines, Singapore, Australia, New Zealand and Japan
.

About Acinetobacter

Acinetobacter is a gram-negative bacterium and an opportunistic human pathogen.
It mainly infects critically ill patients and usually causes severe pneumonia and bloodstream infections; but it can also infect other body parts, such as the urinary tract and Skin
.
Acinetobacter is considered a serious global public health threat, partly because it can acquire multi-drug resistance at a rate never seen in other bacteria
.
Based on the current carbapenem resistance rate, we estimate that there are more than 300,000 hospitalized carbapenem-resistant Acinetobacter infections in the United States, Europe, the Middle East and China each year.
Due to limited treatment options, the incidence of these infections And the mortality rate is very high
.

About Acinetobacter baumannii infection in China

According to the CARSS (National Bacterial Resistance Surveillance Network) 2019 report, there were more than 230,000 Acinetobacter infections in China in 2019, and the actual incidence is estimated to be much higher than this number
.
In 2019, the resistance rate of Acinetobacter baumannii to carbapenem antibiotics is estimated to be 56%, and even as high as 70-80% in some provinces
.
Acinetobacter is also the most common pathogen causing hospital-acquired pneumonia and ventilator-associated pneumonia in China
.
Given the best treatment, the mortality rate of Acinetobacter baumannii infection in China is about 50%
.

Source:

(1) Chinese adult hospital-acquired pneumonia and ventilator-associated pneumonia diagnosis and treatment guidelines (2018 edition)

(2) Chung DR, et al; Asian Network for Surveillance of Resistant Pathogens Study Group.
Am J Respir Crit Care Med 2011; Du, et al.
American Journal of Infection Control 00 (2019) 1 6.

About Zai Lab

Zai Lab (Nasdaq stock code: ZLAB; Hong Kong Stock Exchange stock code: 9688) is a patient-centered and commercialized R&D-based innovative biomedical company dedicated to innovation The development and commercialization of therapies solve the unmet medical needs in the fields of tumors, autoimmune and infectious diseases
.
To achieve this goal, the company's experienced team has established strategic cooperation with the world's leading biopharmaceutical companies to create a broad product pipeline consisting of marketed innovative drugs and products under development
.
Zai Lab has established an internal team with strong drug R&D and translational research capabilities, and is building a proprietary drug candidate pipeline with international intellectual property rights
.
Our vision is to become a leading global biopharmaceutical company, develop and produce its products, and commercialize related products, and work hard to promote the health and well-being of people all over the world
.

Source: Zai Lab