Tetraphase Experimental Bowel Drug Fails To Impress In Late-Stage Trials

Massachusetts-based drug manufacturer Tetraphase Pharmaceuticals reports that its experimental bowel medication failed to reach its primary goal during a late-stage study, causing the company's shares to plummet by as much as 75 percent.

Data gathered from the IGNITE2 trial of the drug known as eravacycline revealed that it performed poorly compared to Johnson & Johnson's levofloxacin antibiotic in alleviating the effects of complicated urinary tract infections.

The result runs opposite with the findings of a previous late-stage study wherein the experimental eravacycline performed better compared to Merck & Co's ertapenem antibiotic.

In a statement released on Tuesday, Tetraphase president and CEO Guy Macdonald said that the company is disappointed at the results of the IGNITE2 trial in which eravacycline was not able to meet its main goal.

He explained that they now plan to conduct further analysis of the data and will provide an update once they finish discussing the results and their plans for the future with different regulatory agencies.

Macdonald added that they had earlier announced the positive findings of eravacycline's IGNITE1 phase 3 clinical trial, wherein the experimental bowel drug was intravenously administered to treat complicated intra-abdominal infections and met its main goal.

The results of the IGNITE1 phase 3 study demonstrated high success rates in treating Gram-negative pathogens as well as a positive safety profile.

Eravacycline is Tetraphase Pharmaceutical's chief drug for treating infections caused by a class of superbugs called gram-negative bacteria that are known to be highly resistant to antibiotic treatment.

The drug maker said that it had expected to submit the bowel medication for approval from regulatory agencies in the United States by the end of the year.

Tetraphase also hopes that eravacycline could be able to compete with several new antibiotic drugs capable of fighting superbugs, such as the recently approved Zerbaxa by Merck & Co.

The failure of the experimental bowl drug dragged the shares of Tetraphase down by as much as $11.23 in extended trading following a closing at $44.78. The company's shares had initially increased by around 45 percent after it announced the findings of the first late-stage study back in December.

Photo: Oliver Dodd | Flickr

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