Fast track designation is intended to expedite the potential availability of a drug candidate to patients which, in the view of the FDA, has the potential to treat a serious or life-threatening condition and to fulfil an unmet medical need.
“With AAI101, Allecra is targeting one of the most frequently encountered bacterial resistance mechanisms seen in hospitals throughout the world, known as ESBLs.”
“Fast track designation for Allecra’s lead product candidate AAI101 not only validates Allecra’s efforts to combat the current antibiotic crisis, but also facilitates our planned Phase III clinical trial, which is now expected to begin this summer,” said Nicholas Benedict, Allecra’s Chief Executive.
Allecra’s lead product candidate, AAI101, is a novel extended spectrum β-lactamase inhibitor designed to overcome resistance of typical Gram-negative hospital pathogens harbouring extended spectrum β-lactamases (ESBLs).
Cefepime/AAI101 is in Phase II clinical development. Cefepime/AAI101 is already granted qualified infectious disease product (QIDP) status and is now granted fast track designation for use in complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI) and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP).
The Centers for Disease Control and Prevention (CDC) has estimated at least 2 million people each year acquire serious infections owing to drug-resistant bacteria in the US alone.
