HM AllecrasmallAllecra Therapeutics, a biopharmaceutical company dedicated to the development of novel antibiotics to combat drug-resistant bacterial infections, has announced initiation of a Phase 2 clinical trial. It will evaluate the efficacy and safety of the combination cefepime/AAI101 for treatment of complicated urinary tract infections (cUTI).

AAI101 is Allecra’s novel, proprietary extended spectrum β-lactamase inhibitor which, when tested with cefepime, has demonstrated excellent efficacy against certain resistant bacteria frequently encountered in hospitals.

The Phase 2 consists of a randomised, double-blind trial with active comparator conducted in up to 63 patients from 38 treatment centres across six European countries. The primary objective of the trial is to define the optimal dose of the combination cefepime/AAI101 delivered intravenously to patients with cUTI. Top line results are expected early in 2018.

Critical threat to public health

The emergence of antibiotic resistance is acknowledged globally to be one of the most critical threats to public health. In the U.S., the Centers for Disease Control and Prevention [CDC] have estimated¹ at least 2 million people each year acquire serious infections due to drug-resistant bacteria. In February 2017, the World Health Organisation published its first-ever list of “priority pathogens”². The “critical” or top priority was assigned to Gram-negative pathogens including ESBL-producing Enterobacteriacae, the key microbiological target for cefepime/AAI101.

Nicholas Benedict, CEO and co-founder of Allecra Therapeutics says: “Emerging bacterial resistance leaves many hospitals in dire need of an effective replacement for empirically-used antibiotics. The ideal replacement for current empirical therapies should be devoid of potential to engender ever more dangerous types of antibiotic resistance. It appears that cefepime/AAI101 combats the most widespread form of Gram-negative bacterial resistance found in hospitals without promoting the emergence and spread of superbugs. An antibiotic with this profile should be a useful addition to hospital physicians’ armamentarium against bacterial resistance.”

Professor George Drusano, Professor of Medicine and Director of the Institute of Therapeutic Innovation at the University of Florida, member of Allecra’s Scientific Advisory Board, comments: “In early testing, it was shown that Allecra’s new β-lactamase inhibitor, AAI101, has potential for use in combination with cefepime to become an effective workhorse antibiotic. The combination overcomes much of the resistance we see towards the antibiotics we use most often.”

Professor Patrice Nordmann, Head of the Molecular Microbiology Unit of the Department of Medicine at the University of Fribourg, Switzerland, another of Allecra’s Scientific Advisors and close partners, adds: “The majority of Gram-negative bacterial resistance in hospitals is caused by dissemination of extended spectrum β-lactamases (ESBLs). The novel combination of cefepime and AAI101 so far has demonstrated excellent efficacy against bacteria expressing ESBLs, including those resistant to the leading antibiotic used for such infections, piperacillin/tazobactam.”

Cefepime/AAI101 for intravenous use is designated Qualified Infectious Disease Product (QIDP) by the United States Food and Drug Administration for the treatment of cUTIs, complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP), and for ventilator-associated bacterial pneumonia (VABP).

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1 Centers for Disease Control and Prevention, U.S. Department of Health and Human Services Antibiotic Resistance Threats in the United States, 2013 

2 World Health Organisation Priority Pathogens List for R&D of New Antibiotics, 27 February 2017