Patients with complicated intra-abdominal infections achieved clinical response with eravacycline

Positive preliminary results from the phase 3 IGNITE 1 trial indicate that eravacycline is non-inferior to ertapenem in achieving clinical response in patients with complicated intra-abdominal infections, the manufacturer announced.

Eravacycline (Tetraphase Pharmaceuticals) is a broad-spectrum intravenous and oral antibiotic in development in the Investigating Gram-negative Infections Treated with Eravacycline (IGNITE) program, which includes two ongoing phase 3 clinical trials: IGNITE 1 for the indication of complicated intra-abdominal infections and IGNITE 2 for complicated urinary tract infections, according to a press release. The FDA has designated eravacycline as a qualified infectious disease product for both indications.

“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,” Joseph Solomkin MD, professor emeritus in the department of surgery at the University of Cincinnati College of Medicine and Tetraphase adviser, said in the release. “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.”

IGNITE 1 aims to determine the efficacy and safety of 1 mg/kg intravenous eravacycline given every 12 hours compared with 1 g intravenous ertapenem every 24 hours in the treatment of complicated intra-abdominal infection, the release said. The trial includes 541 adults from 66 international centers, and the primary endpoint based on guidance from the FDA and EMA is clinical response at the test-of-cure visit, which was achieved, according to the release.

“The positive results from IGNITE 1 underscore that treatment with eravacycline could help a significant number of [complicated intra-abdominal infection] patients achieve a clinical cure for their difficult-to-treat Gram-negative infections,” Guy Macdonald, president and CEO of Tetraphase, said in the release. “The success of this trial is an important milestone for the eravacycline pivotal program. These results, along with those from our ongoing phase 3 IGNITE 2 trial in complicated urinary tract infections which are expected in mid-2015, would form the basis of regulatory submissions seeking approval for eravacycline in both indications. We continue to target a new drug application submission to the FDA by the end of 2015.”

The company plans to present IGNITE 1 data at a scientific meeting in the coming year, the release said.