Tetraphase Pharmaceuticals, Inc. (TTPH) is working hard to develop its pipeline. We believe the pipeline at Tetraphase must deliver to facilitate the company’s long-term growth. Currently, the company does not have any marketed products.
The lead pipeline candidate at Tetraphase is eravacycline. The candidate is being developed for many indications including complicated urinary tract infections (cUTI) and complicated intraabdominal infections (cIAI).
Tetraphase has revealed the design of the phase III IV/oral study on eravacycline, for the treatment of cUTI patients. The study is expected to be initiated by year end. The randomized, multi-center, double-blind study will compare the safety and efficacy of eravacycline against Johnson & Johnson’s (JNJ) Levaquin (levofloxacin) in cUTI patients.
This study will be carried out in two parts. The first part will be the lead-in portion of the study consisting 120 patients. Tetraphase stated in its press release that after the lead-in portion, an interim analysis will be conducted to assess the primary efficacy, safety and tolerability endpoints for determining the dosage to be used in the second part of the study.
The second part of the study will enroll 720 patients. They will be administered the selected dosage of either eravacycline or Levaquin. Clinical and microbiological response around seven days following the completion of the therapy will be the primary endpoint of this part of the phase III study.
We note that eravacycline is also being evaluated in a separate phase III study for treating cIAI patients. Tetraphase enrolled the first patient in this randomized, double-blind, double-dummy, multicenter, prospective clinical study in Aug 2013.
Tetraphase intends to enrol 536 adults for the study in around 100 centers around the globe. Tetraphase will be evaluating the efficacy, safety and pharmacokinetics of eravacycline in comparison to Merck & Co. Inc.’s (MRK) Invanz (ertapenem) in patients suffering from cIAI. We expect investor focus to stay on the development of eravacycline.
Tetraphase presently carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Actelion Ltd. (ALIOF) with a Zacks Rank #1 (Strong Buy).
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