Supports Allecra’s lead program in Phase 2 clinical trials to treat serious Gram-negative infections
Lörrach, Germany and Saint Louis, France – Allecra Therapeutics, a biopharmaceutical company dedicated to the development of novel antibiotics for the treatment of drug-resistant bacterial infections, announces today that the U.S Food and Drug Administration (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.
“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 3 clinical trial which is now expected to begin this summer” commented Nicholas Benedict, Allecra’s Chief Executive.
Fast Track designation is intended to expedite the potential availability of a drug candidate to patients which, in the view of FDA, has the potential to treat a serious or life-threatening condition and to fulfill an unmet medical need.
Allecra’s lead product candidate, AAI101, is a novel Extended Spectrum β-lactamase inhibitor which is designed to overcome resistance of typical Gram-negative hospital pathogens harboring Extended Spectrum β-lactamases (ESBLs). Cefepime/AAI101 is in Phase 2 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] have estimated that at least 2 million people each year acquire serious infections due to drug-resistant bacteria in the U.S. alone.
