Tetraphase Pharmaceuticals, Inc. (TTPH - Free Report) announced the completion of patient enrolment for the lead-in portion of the phase III IGNITE 2 study on eravacycline. The two-part phase III study is evaluating the safety and efficacy of eravacycline (both oral and intravenous formulations) for the treatment of complicated urinary tract infections (cUTI).
The IGNITE 2 study will compare eravacycline with Johnson & Johnson’s (JNJ - Free Report) Levaquin (levofloxacin) in cUTI patients. Patients enrolled in the lead-in portion of the study will be randomized (1:1:1) to receive eravacycline in one of two IV-to-oral step down dosing cohorts or levofloxacin. Data from the lead-in portion of the study is anticipated in the third quarter of 2014.
An evaluation of primary efficacy, safety, and tolerability endpoints will be conducted in a planned interim analysis after the completion of the lead-in portion of the trial. The interim analysis will decide the dose regimen which will be carried forward to the next portion of the trial. In the second portion of the study, patients will be randomized (1:1) to receive the selected dose regimen of eravacycline or levofloxacin.
We note that Tetraphase is already enrolling patients for the phase III IGNITE 1 study on eravacycline under the company’s IGNITE program. The randomized, multi-center, double-blind, double-dummy study is designed to evaluate the efficacy and safety of eravacycline in comparison to Merck & Co. Inc.’s (MRK - Free Report) Invanz (ertapenem) in complicated intra-abdominal infections (cIAI) patients. Top-line data from the study is expected in the first quarter of 2015.
We note that eravacycline enjoys qualified infectious disease product (QIDP) designation from the FDA for the cIAI and cUTI indications. The QIDP designation is a part of the Generating Antibiotic Incentives Now Act, which falls under the 2012 FDA Safety and Innovation Act. With eravacycline being designated a QIDP, Tetraphase will benefit from incentives such as priority review. Eravacycline will also be eligible for the FDA's "fast track" status and will enjoy an additional five years of exclusivity once it is approved.
We believe the successful development of eravacycline is crucial for Tetraphase. We expect investor focus to remain on the candidate going forward.
Tetraphase carries a Zacks Rank #4 (Sell). Some better ranked stocks in the healthcare segment include Ariad Pharmaceuticals Inc. . The stock carries a Zacks Rank #2 (Buy).