Tetraphase provides clinical update on lead antibiotic candidate and Phase 3 clinical program

Tetraphase Pharmaceuticals, Inc.Mar 21 2014

Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today provided a clinical update on its lead antibiotic candidate, eravacycline, and its Phase 3 global clinical program IGNITE (Investigating Gram-negative Infections Treated with Eravacycline). Tetraphase is developing eravacycline as a potent new broad-spectrum antibiotic to treat multidrug-resistant (MDR) infections, including those caused by many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the Centers for Disease Control and Prevention (CDC) in September 2013.

The Company announced today that 50% of targeted enrollment has been achieved in IGNITE 1, which it initiated in late August 2013 to investigate the safety and efficacy of eravacycline in the treatment of complicated intra-abdominal infections (cIAI). The company also announced that it has begun patient enrollment in IGNITE 2, the company's two-part Phase 3 clinical trial studying the safety and efficacy of intravenous (IV) and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI).

Tetraphase continues to expect to have data from the lead-in portion of IGNITE 2 in mid-2014, top-line data from IGNITE 1 in the first quarter of 2015, and top-line data from IGNITE 2 in mid-2015; and to file for U.S. regulatory approval of eravacycline for both indications by the end of 2015.

"The rate of enrollment in IGNITE 1 is encouraging and indicative of strong investigator enthusiasm for eravacycline," said Guy Macdonald, President and CEO of Tetraphase. "Eravacycline remains the only late-stage antibiotic being developed for intravenous and oral dosing against MDR Gram-negative infections, underscoring its significant potential in both indications being pursued. We believe IV-to-oral step-down use is particularly important in light of the rising incidence of resistance to current standards of care that use the IV-to-oral step-down treatment paradigm. In the near-term, we look forward to the results from the lead-in portion of the IGNITE 2 trial in mid-2014 and to selecting an optimal oral dose to take forward into the pivotal portion of the trial."

Eravacycline has been designated by the U.S. Food and Drug Administration as a Qualified Infectious Disease Product (QIDP) for both the cIAI and cUTI indications. This designation, which is assigned to qualifying new antibiotic product candidates, makes eravacycline eligible to benefit from certain development and commercialization incentives, including priority review, and eligibility for both fast-track status and an additional five years of U.S. market exclusivity.