Tetraphase antibiotic holds up in Phase 3
- Tetraphase Pharmaceuticals experimental tetracycline antibiotic met its primary endpoint in a Phase 3 study, demonstrating non-inferiority to ertapenem, the Watertown, MA-based biopharma said Thursday.
- The antibiotic, known as eravacycline, is designed to complicated intra-abdominal inefections (cIAIs) and other infections caused by multidrug-resistant pathogens.
- Another Phase 3 study comparing eravacycline with meropenem is set to read out in the fourth quarter of next year. Together the two studies will form the basis of a new drug application to the Food and Drug Administration, Tetraphase said.
Treating patients with complicated intra-abdominal infections can be challenging, and failure can increase morbidity and mortality, slow recovery and increase overall cost. Tetraphase hopes eravacycline can fill a need in cIAI and urinary tract infections.
"Eravacycline has potent activity against a wide range of bacteria — Gram-negative, Gram-positive and anaerobes, including drug-resistant bacteria on the CDC’s dangerous threat list," said Tetraphase CEO Guy Macdonald in an interview with BioPharma Dive.
"We believe [eravacycline] has the potential to be used not only for those difficult-to-treat infections but also as first-line treatment for high-risk patients, particularly in geographic areas or hospitals where drug resistance is more of a problem," Macdonald said.
Antibiotic drug development is challenging and as antibiotic resistance grows governments are urging physicians to prescribe less frequently, a potential check on revenue opportunities.
With eravacycline, Tetraphase has elected to develop a drug from an existing class, rather than creating a new class.
"Tetraphase’s chemistry technology enables the design of fully synthetic antibiotics that have the ability to overcome common tetracycline resistance mechanisms, while at the same time having potent activity against bacteria resistant to other antibiotic classes like beta-lactams, quinolones, and other tetracyclines," said Macdonald.
Results of the Phase 3 IGNITE 1 study were published Nov. 16 in JAMA Surgery.
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