Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH) has revealed that it will be seeking the approval of the U.S. Food and Drug Administration early next year following the success of one of its antibiotics in a late-phase trial. Known as eravacycline, the antibiotic was found to be effective in the treatment of complicated intra-abdominal infections.
In the trial, 500 patients participated and no adverse side effects were observed except for infusion site reactions such as vomiting and nausea in less than 5% of the study participants. Tetraphase will be seeking the approval of the Food and Drug Administration next year in Q1 as well as approval from European regulators in 2017’s third quarter.
“We believe that eravacycline has the potential to play a key role in the treatment of serious hospital infections, and we are another step closer to realizing that goal,” said Guy MacDonald, the chief executive officer of Tetraphase in a statement.
Drug-resistant infections
With an employee headcount of 66, Tetraphase is one of the biotechnology firms focusing on finding treatments for infections that are drug-resistant. Every year these infections cost the lives of about 700,000 people around the world. In the United States the number of lives that are lost due to superbugs is about 23,000.
Additionally Tetraphase has also unveiled the third phase trial of the drug for patients who are suffering from urinary tract infections that are complicated. Two years ago a third phase study of eravacycline in a similar patient category failed.
Oral formulation
An oral eravacycline formulation is also being developed by Tetraphase. Already, first phase clinical studies have been completed with a view to identifying the optimal exposure and dosing regimen. More clinical testing is also being undertaken and updates will be provided in the 3rd quarter of this year.
Founded a little over ten years ago, Tetraphase went public seven years after its formation. Earlier in the year Tetraphase received $4 million from an accelerator program based in Boston known as Carb-X and which funds individuals and entities involved in developing antibacterial drugs that are potentially life-saving.
On Wednesday shares of Tetraphase Pharmaceuticals Inc rose by 14.20% to close the day at $7.88.
