Fast-Track Status for Tetraphase Candidate


Shares of Tetraphase Pharmaceuticals, Inc. (TTPH) were up 2.5% after the company received Fast Track designation from the U.S. Food and Drug Administration (:FDA) for its lead antibiotic candidate, eravacycline (both for the intravenous (:IV) and oral formulations).

The candidate is currently being evaluated in two phase III studies, IGNITE 1 and IGNITE 2. The enrollment process for the IGNITE 1 study on eravacycline for complicated intraabdominal infections (cIAI) is currently in progress. The company has completed enrolling 50% of the targeted 536 patients for the study, which commenced in the second quarter of 2013.

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 in cIAI patients. Top-line data from the study is expected in the first quarter of 2015.

Tetraphase has also started enrolling patients for the IGNITE 2 study on eravacycline. The two-part study is designed to evaluate the safety and efficacy of intravenous and oral versions of the candidate for treating patients suffering from complicated urinary tract infections (cUTI). Data from the lead-in portion of the study is anticipated in mid-2014. Tetraphase expects top-line data from the IGNITE 2 study in mid-2015 and seek U.S. approval for the candidate for both indications by the end of 2015.

We note that eravacycline already enjoys qualified infectious disease product (:QIDP) designation from the FDA for the cIAI and cUTI indications. With eravacycline being designated a QIDP, Tetraphase will benefit from incentives such as priority review and will enjoy an additional five years of exclusivity once approved.

We expect investor focus to stay on the development of eravacycline. Tetraphase carries a Zacks Rank #4 (Sell). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Questcor Pharmaceuticals, Inc. (QCOR) and Shire (SHPG), both carrying a Zacks Rank #1 (Strong Buy).

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