Shares of Tetraphase Pharmaceuticals (NASDAQ: TTPH) were zooming ahead about 25% in pre-market trading Wednesday after the drug maker said its lead drug candidate for serious bacterial infections met its primary endpoint in a phase 3 study.
The Watertown, Massachusetts-based biopharmaceutical company was evaluating eravacycline, an IV-administered synthetic derivative of tetracycline, in the 500-patient trial, dubbed IGNITE4, for the treatment of complicated intra-abdominal infections (cIAI).
cIAI are frequently caused by multidrug-resistant pathogens that have been a hot topic in recent years on a global scale due to a need for development of new antibiotics to combat a growing drug resistance problem.
The goal of the trial was to show that twice-daily intravenous eravacycline was statistically comparable to the broad-spectrum antibiotic meropenem at knocking out the infection. Meropenem, a type of carbapenem, has been around for over twenty years, approved by the FDA in 1996 and originally marketed by AstraZeneca (NYSE: AZN).
In the study, Tetraphase said that eravacycline indeed demonstrated statistical non-inferiority to meropenem for the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit. Cure rates for both topped 90%, with no serious adverse events reported in the study.
IGNITE4 was the second of two pivotal trials of twice-daily eravacycline for cIAI. Separately, Tetraphase is conducting IGNITE3, a study looking at once-daily IV infusions of eravacycline for complicated urinary tract infections, and early clinical research on an oral formulation of the experimental drug.
With the successful completion of IGNITE4, Tetraphase intends to submit a new drug application to the FDA in the first quarter of 2018. A marketing authorization application is also being prepared for the European Medicines Agency, with expectations for a submission during this quarter.
After closing Tuesday at $6.90, shares of TTPH were printing $8.65 in pre-market trading Wednesday.
BMO Capital took the positive data as reason to bump up its price target, lifting it to $13.00 from $12.00 while maintaining its “outperform” rating on Tetraphase.
Related Stories
