Antibiotic Entasis is the best drug of last resort in the Phase 3 trial; FDA filing scheduled for 2022

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Entasis Therapeutics has progress to report in its quest to provide patients with an antibiotic capable of killing drug-resistant bacteria. The company’s lead antibiotic candidate has met the primary goal of a pivotal study, paving the way for an expected FDA submission next year.

Target pathogens, Acinetobacter baumanii, are opportunistic bacteria that mainly infect critically ill patients who are already immunocompromised. These bacteria pose a particular challenge in healthcare settings because they have the ability to rapidly develop resistance to several existing drugs more quickly than other bacteria. This resistance creates a need for new antibiotics for hospitals around the world. Drug resistant infections caused by A. baumannii often lead to death.

Entasis’ lead product candidate, SUL-DUR, combines the old antibiotic sulbactam with durlobactam, a new antibiotic from the company. Entasis, based in Waltham, Mass., Is developing SUL-DUR as a treatment for infections caused by A. baumannii, including those derived from strains resistant to carbapenems, a broad-spectrum antibiotic currently in use.

Entasis tested SUL-DUR in a global phase 3 clinical trial involving 207 patients. The study was divided into two parts: Part A compared SUL-DUR with colistin, a last-resort antibiotic used to treat drug-resistant infections, and Part B, an open-label test of the drug in patients with infections were resistant to or had failed treatment with colistin or polymyxin B, another antibiotic. The main objective of the study was to show efficacy by measuring all-cause mortality rates after 28 days.

According to preliminary results released Tuesday, the drug Entasis met the primary goal of Part A, with 12 of 63 patients dying (19%) versus 20 deaths of 62 patients (32.3%) in the colistin arm. In testing for infection to determine if a patient is cured, clinical cure – resolution of all signs and symptoms – was observed in 61.9% of patients treated with SUL-DUR compared with 40.3% in SUL-DUR. colistin arm. These results were statistically significant. In part B, the mortality was consistent with part A. In addition to the efficacy results, the drug Entasis showed better safety compared to colistin. In both parts A and B, renal toxicity was observed in 12 of 91 patients (13.2%) compared to 32 of 85 (37.6%) in the colistin arm.

Keith Kaye, head of the division of allergies, immunology and infectious diseases at Robert Wood Johnson Medical School, and chair of the data security oversight committee for the SUL-DUR clinical trial, said the Acinetobacter infections are among the most difficult to treat. , while representing a burden on health resources and patients.

“Data from [SUL-DUR] The trials are robust and incredibly exciting, demonstrating positive results in safety and efficacy, combined with favorable and significant clinical cure rates, ”Kaye said in a prepared statement. “If approved by regulatory bodies, SUL-DUR will address the urgent need for new treatment options for patients with life-threatening infections caused by Acinetobacter species, including multidrug resistant strains.

With the results of Phase 3 in hand, Entasis plans to submit a new drug application to the FDA in mid-2022, according to an investor presentation. Entasis owns the worldwide rights to SUL-DUR, with the exception of the Asia-Pacific region, where Zai Labs has licensed the exclusive rights to develop and commercialize the drug.

Although drug-resistant bacteria have a clear medical need, most of the big drug companies have abandoned research on antibiotics. Entasis is the product of this trend. The company is AstraZeneca’s former anti-infective unit, which turned the division into a separate company in 2015. Biotech went public three years later, raising around $ 75 million. Entasis’ pipeline includes zoliflodacin, which is an advanced drug candidate for uncomplicated gonorrhea, and the candidate for complicated urinary tract infections ETX0282CPDP, which is in phase 1.

Public domain image by CDC


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