December 18, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Tetraphase Pharmaceuticals is riding high Thursday, after news that its antibiotic eravacycline stacked up well to competitors in late-stage clinical testing sent its stock up almost 17 percent to rest at $38.79 in midday trading.
The results from the Phase 3 IGNITE 1 Clinical Trial have Wall Street watchers betting that Tetraphase may have found a therapy that could help combat that growing and dangerous trend of antibiotic-resistant infections.
Recent data from the Centers for Disease Control and Prevention said that those types of infections have been linked to 23,000 deaths and 2 million illnesses in the United States annually—making solving the problem a top priority for insurers, healthcare providers and investors alike.
Eravacycline is the company’s primary drug candidate—though it went public last year, it does not currently have any products on the market.
In the trial results reported by the Watertown, Mass.-based company, eravacycline met the primary endpoint of statistical non-inferiority of clinical response at the test-of-cure (TOC) visit, under the guidance set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA.
“The prevalence of potentially deadly, multi-drug-resistant bacterial infections has grown rapidly in recent years and is currently a major global public health concern, especially in resistant Gram-negative infections where many current antibiotic treatment options are increasingly ineffective,” said Joseph Solomkin, Tetraphase advisor and professor emeritus in the department of surgery at the University of Cincinnati College of Medicine.
“These IGNITE 1 trial results suggest that eravacycline has the potential to be a new treatment option for serious intra-abdominal infections, and possibly other serious bacterial infections, where new treatments are urgently needed for patients,” he said.
Tetraphase said it is still conducting another late-stage study of eravacycline in patients with complicated urinary tract infections, with results slated for mid-2015. If all goes well, it aims to submit the drug to the FDA by the end of next year.
For those crunching the hard numbers, Tetraphase said the primary analysis under the FDA guidance was conducted using a 10 percent non-inferiority margin in the microbiological intent-to-treat (micro-ITT) population. In the micro-ITT population, the lower and upper bounds of the 95 percent confidence interval were -7.1 percent and 5.5 percent, respectively. Under the EMA guidance, the primary analysis was conducted using a 12.5 percent non-inferiority margin of the clinically evaluable (CE) patient population. In the CE population, the lower and upper bounds of the 95 percent confidence interval were -6.3 percent and 2.8 percent, respectively.
“The secondary analyses were consistent with and supportive of the primary outcome,” said the firm in a statement.
“The positive results from IGNITE 1 underscore that treatment with eravacycline could help a significant number of cIAI patients achieve a clinical cure for their difficult-to-treat Gram-negative infections,” said Guy Macdonald, president and CEO of Tetraphase.
