Posted by Michael Wonder on 17 Feb 2018
Allecra Therapeutics announces fast track designation for lead antibiotic in resistant infections
14 February 2018 - Supports Allecra’s lead program in Phase 2 clinical trials to treat serious gram-negative infections.
Allecra Therapeutics announces today that the U.S FDA has granted fast track designation for the company’s lead product candidate AAI101 when given in fixed dose combination with the antibiotic cefepime, a powerful treatment for serious hospital-acquired Infections.
Allecra’s lead product candidate, AAI101, is a novel extended spectrum β-lactamase inhibitor designed to overcome resistance of typical Gram-negative hospital pathogens harboring Extended Spectrum β-lactamases. Cefepime/AAI101 is in Phase 2 clinical development. Cefepime/AAI101 is already granted qualified infectious disease product status and is now granted fast track designation for use in complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.
