- Tetraphase Pharmaceuticals announced after the close of the market on Tuesday that its Phase 3 antibiotic showed positive results when tested against the antibiotic Merrem (meropenem).
- In the late-stage IGNITE 4 study of 500 patients with complicated intra-abdominal infections (cIAI), Eravacycline proved to be non-inferior to Merrem (meropenem), one of a limited number of antibiotics used for the complicated, and oft-serious, infections.
- Shares of the company’s stock jumped more than 22% in pre-market trading on Wednesday and continued to gain into early morning trading, climbing another 9.2% to sit at $7.53 apiece.
The topline data showed that in the microbiological-intent-to-treat population, eravacycline showed a clinical cure rate of 90.8%, whereas patients on Merrem showed a clinical cure rate of 91.2%. This is the endpoint that the Food and Drug Administration will look at for approval.
Meanwhile, in the clinically evaluable population, eravacycline patients achieved a clinical cure rate of 96.9%, compared with 96.1% for Merrem patients. This is the endpoint that the European Medicines Agency will use to evaluate approvability.
Antibiotic resistance has become an increasingly growing problem —particularly in hospitals where complicated infections are rampant. This increased resistance has made the development of new antibiotics even more important.
"Collectively, the data from the IGNITE program in cIAI versus two widely-used comparators, ertapenem and meropenem, provides compelling evidence for IV eravacycline monotherapy and its potential to be a valuable new addition to the limited toolkit currently available to treat serious, and often life-threatening MDR infections," said Joseph Solomkin, an advisor to the company and professor emeritus in the Department of Surgery at the University of Cincinnati College of Medicine.
Tetraphase plans to submit a New Drug Application to the FDA in the first quarter of 2018 and will seek approval from the EMA even earlier, in the third quarter of this year.
Further results from the study will be presented at an upcoming medical meeting.