FDA Fast Tracks Tetraphase's Eravacycline Antibiotic

Tetraphase Pharmaceuticals, Inc. announced in a press release that the Food & Drug Administration (FDA) has given Fast Track status to eravacycline. The federal agency approved the designation for two formulations, the intravenous (IV) and the oral formulations of the antibiotic. The FDA’s designation underscores the need for antibiotics and allows the company to correspond and meet more frequently with the FDA and submit portions of the New Drug Application (NDA) as available. Guy Macdonald, President and CEO of Tetraphase said, "We are delighted that eravacycline has received Fast Track designation for both formulations and for both therapeutic indications being pursued. There is a serious and growing public health threat as a result of the rise in increasingly difficult-to-treat bacterial infections, particularly those caused by multidrug-resistant Gram-negative bacteria.”

Eravacycline Indications

Tetraphase received approval to investigate eravacycline in two indications: complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI). Per the FDA’s guidance on cUTIs, these infections involve

functional or anatomical abnormalities of the urinary tract in women and men or are induced by specific bacteria, and should be distinguished from uncomplicated UTIs. The FDA stated in a guidance on cIAIs that intra-abdominal infections are common. Infections can arise from a number of sources including a wide variety of bacteria. These infections may occupy the peritoneal cavity or the viscera. Those that occupy the peritoneal or retroperitoneal cavity are considered complicated infections.

Eravacycline

Eravacycline is Tetraphase’s leading drug candidate with promise in treating drug-resistant infections including those from gram-negative bacteria. Eravacycline is a synthetic tetracycline antibiotic derived using proprietary methods. It was selected for development based on in vitro studies that indicated activity against multiple types of bacteria, its promise as a first line therapy, and its ability for injection or oral administration. Studies have demonstrated its potency against Acinetobacter baumannii and Enterobacteriaceae.

IGNITE 1 and IGNITE 2

IGNITE 1 and IGNITE 2 (Investigating Gram-negative Infections Treated with Eravacycline) trial results are due in the middle of 2015. Tetraphase intends to file for FDA approval by the end of 2015. The IGNITE 1 study will evaluate safety and efficacy of eravacycline (IV formulation) in complicated intra-abdominal infections (cIAI). IGNITE 2 will test eravacycline (IV-to-oral step-down therapy) for the treatment of complicated urinary tract infections (cUTI).