A new antibiotic by Entasis Therapeutics has bested an existing therapy against a pathogen deemed by the Centers for Disease Control and Prevention (CDC) to be an urgent threat during a phase 3 clinical trial.
The Zai Lab-partnered drug, called SUL-DUR, will now be headed for an initial FDA filing in mid-2022, Entasis said in a Monday statement.
SUL-DUR was being tested for efficacy against infections caused by Acinetobacter baumannii in the phase 3 ATTACK trial. Acinetobacter bacteria can cause infections in the blood, urinary tract and lungs. While often nonsymptomatic, the bacteria can cause serious complications and are notorious for resisting existing treatments.
Entasis’ therapy met the main goal of the trial, which was 28-day all-cause mortality compared to colistin, a common antibiotic used as a last resort against multidrug-resistant Gram-negative infections. SUL-DUR was found to be noninferior to colistin with a favorable safety profile and tolerability. The death rate in the SUL-DUR arm was 19% compared to 32% in the colistin group.
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SUL-DUR also beat colistin in reducing nephrotoxicity, a rapid deterioration of kidney function associated with certain medications. The rate of nephrotoxicity seen with the Entasis drug was 13% compared to 38% in those taking colistin. A lower rate of adverse events was also reported with the SUL-DUR group.
Acinetobacter has been named one of the CDC’s biggest antibiotic resistance threats in the U.S. Infections with this bacteria happen most often in patients who recently received care in a healthcare facility. An estimated 8,500 patients were hospitalized due to these infections in 2017, and 700 died.
Zai Lab Chairperson and CEO Samantha Du, Ph.D., said these infections remain a persistent problem in Chinese ICUs and result in a high death rate.
Entasis spun out of AstraZeneca with an antibiotic drug discovery platform and funding in 2015. The biotech hit the public markets in 2018 with a $75 million IPO and a mission to develop new antibiotics.
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Interest in developing new drugs to combat antibiotic resistance has been growing, with Big Pharma heavyweights like Pfizer, Johnson & Johnson and Merck getting in on the game to support smaller biotechs in their missions. Entasis is backed by Novo Holdings’ REPAIR Impact Fund, which aims to support antibiotic resistance startups.
The U.S. federal government has also offered up funding for companies working on new antibiotics.