Tetraphase Pharmaceuticals, Inc
) 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)
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 (
) 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
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 (
) 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
Tetraphase carries a Zacks Rank #4 (Sell). Avanir
Pharmaceuticals Inc. (
) is a better-ranked stock in the health care segment with a Zacks
Rank #2 (Buy).
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