Date: 2017-09-06
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Allecra Therapeutics (France - Germany)
Product: AAI101 and cefepime
Action
mechanism:
- antibiotic/cephalosporin/beta-lactamase inhibitor. AAI101 is an extended-spectrum ß-lactamase inhibitor belonging to the penicillanic acid sulfone class that exhibits potent in vitro and in vivo activity against many resistant Gram-negative pathogens. The clinical development program is focused on combining AAI101 with well-established ß-lactam antibiotics in order to restore their effectiveness:
- Cefepime is a 4th generation cephalosporin, used for the treatment of many serious hospital infections, including complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI) and hospital-acquired pneumonia (HAP).
- Cefepime/AAI101 for intravenous use is designated Qualified Infectious DiseaseProduct (QIDP) by the FDA for the treatment of cUTIs, complicated intra-abdominal infections (cIAI), hospital-acquired bacterialpneumonia (HABP) and for ventilator-associated bacterial pneumonia (VABP).
Disease: complicated urinary tract infections (cUTI)
Therapeutic
area: Infectious diseases
Country:
Trial
details:
Latest
news:
- • On September 6, 2017, Allecra Therapeutics, a biopharmaceutical company dedicated to the development of novel antibiotics to combat drug-resistant bacterial infections, announced the initiation of a Phase 2 clinical trial to evaluate the efficacy and safety of the combination cefepime/AAI101 for treatment of complicated urinary tract infections (cUTI).
The Phase 2 consists of a randomized, double-blind trial with active comparator conducted in up to 63 patients from 38 treatment centers 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.
- Prof. 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, commented: “In early testing, it was shown that Allecra’s new ?-lactamase inhibitor, AAI101, has potential for use in combination with cefepime tobecome an effective workhorse antibiotic. The combination overcomes much of the resistance we currently see towards the antibiotics we use most often.” Prof. 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, added: “The majority of Gram-negative bacterial resistance in hospitals is caused by dissemination of extended spectrum ?-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.”
Is
general: Yes
