Pipeline updates by pharma/biopharma companies are of immense value to investors interested in the sector. Investors, more often than not, make their decisions on whether to invest in a particular stock from the above sector based on such updates.
Tetraphase Pharmaceuticals, Inc. (TTPH - Free Report) is working hard to develop its pipeline. Eravacycline is the lead pipeline candidate at Tetraphase. Eravacycline, an antibiotic, is being evaluated for multiple indications.
The company, while providing an update on eravacycline last week, said that the enrollment process for the phase III study (IGNITE 1) on eravacycline in the complicated intraabdominal infections (cIAI) indication is 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 - Free Report) Invanz (ertapenem) in cIAI patients. Top-line data from the study is expected in the first quarter of 2015.
Tetraphase has also started enrolling patients for another phase III study (IGNITE 2) 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. The company 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 that year.
We note that eravacycline enjoys qualified infectious disease product (QIDP) designation from the U.S. Food and Drug Administration (FDA) for the cIAI and cUTI indications. The QIDP designation is a part of the Generating Antibiotic Incentives Now (GAIN) Act, which falls under the 2012 FDA Safety and Innovation Act (FDASIA).
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. Apart from Tetraphase, companies such as Cubist Pharmaceuticals have also benefited from the signing of the GAIN act.
We expect investor focus to stay on the development of eravacycline.
Tetraphase carries a Zacks Rank #4 (Sell). Questcor Pharmaceuticals, Inc. is a better-ranked stock with a Zacks Rank #1 (Strong Buy).