Tetraphase Pharmaceuticals submits its New Drug Application to the FDA for its investigational drug candidate, eravacycline, for the treatment of complicated intra-abdominal infections.
Today, January 2, 2018, Tetraphase Pharmaceuticals just announced that it has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational drug candidate, eravacycline, in IV form, for the treatment of complicated intra-abdominal infections (cIAI).
Eravacycline is a novel, fully-synthetic fluorocycline broad-spectrum antibiotic developed to treat serious, life-threatening multidrug-resistant bacterial infections and happens to be Tetraphase’s “lead product candidate.”
At the 9th IAS Conference on HIV Science, Patrick Horn, MD, PhD, chief medical officer at Tetraphase discussed with Contagion ® what makes the antibiotic unique. “There are several things that make eravacycline a unique antibiotic. One of the biggest ones is its range of coverage. Even within the multidrug-resistant gram-negative pathogens, it covers most of the known resistance mechanisms,” he said. “For example, if you look at carbapenem resistance, the Amber classes A-D, some of the new antibiotics in development cover some of those, but none of them cover all, especially the metalloproteases, and eravacycline covers all of them. It covers Acinetobacter, which is also not covered well by some of the new compounds in development.”
Furthermore, eravacycline also covers gram-positive bacteria, including methicillin-resistant Staphylococcus aureus, “and so it offers the potential for some early use before the resistance is known and before the pathogen is known,” he added. As it’s not a beta-lactam, it can potentially be used by those who have beta-lactam allergies.
“The submission of the NDA filing for IV eravacycline, supported by positive data from two pivotal trials investigating the drug for the treatment of cIAI, is a critical milestone for Tetraphase,” Tetraphase’s president and CEO Guy Macdonald, said in the press release.
The trials are a part of the company’s IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) phase 3 program. The NDA submission includes data specifically from the IGNITE1 and IGNITE 4 phase 3 clinical trials, where IV eravacycline, taken twice-daily, was found to be well-tolerated and to have achieved high clinical cure rates in patients suffering from cIAI. “Both studies demonstrated statistical non-inferiority of eravacycline to 2 widely used comparators—ertapenem in IGNITE 1 and meropenem in IGNITE4—for the primary efficacy endpoint clinical response at the test-of-cure visit,” the press release reads.
“We believe that eravacycline has the potential to play a key role in the treatment of serious hospital infections, particularly Gram-negative infections,” Macdonald stressed in the press release. “We are now one step closer to realizing the goal of bringing this medicine to the market.”