Shares of Tetraphase Pharmaceuticals, Inc. (TTPH) were up after the company reported positive top-line results on its lead pipeline candidate eravacycline from the IGNITE 2 ((Investigating Gram-negative Infections Treated with Eravacycline) study.
IGNITE 2 is a two part phase III study evaluating the efficacy and safety of intravenous (:IV) and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI) versus Johnson & Johnson’s (JNJ) Levaquin (levofloxacin).
The data from the lead-in portion of the study showed both IV-to-oral dosing regimens of eravacycline (1.5 mg/kg IV followed by 200 mg or 250 mg) compared favorably to Levaquin. In addition, the data from the study showed that the pharmacokinetics of both oral doses of eravacycline were comparable to the IV formulation.
Tetraphase plans to share the results of the IGNITE 2 study with the FDA and confirm the appropriate dose to carry forward into the pivotal portion of the trial.
Tetraphase remains on track to initiate this stage of the trial in early 2014.
The full data from the lead-in portion of the trial will be presented in an upcoming meeting.
We note that Tetraphase completed enrolling patients for the phase III IGNITE 1 study on eravacycline under the company’s IGNITE program in Jul 2014. 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) Invanz (ertapenem) in complicated intra-abdominal infections (cIAI) patients. Top-line data from the study is expected in the first quarter of 2015.
We believe the successful development of eravacycline is crucial for Tetraphase. We expect investors to react positively to the data news.
Tetraphase carries a Zacks Rank #4 (Sell). Avanir Pharmaceuticals Inc. (AVNR) is a better-ranked stock in the health care segment with a Zacks Rank #2 (Buy).