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news.Tetraphase Pharmaceuticals has received guidance from the U.S. Food and Drug Administration (FDA) regarding the regulatory path of the Company's lead candidate, eravacycline, an antibiotic with potent activity against drug-resistant bacteria, including MDR pathogens highlighted as urgent public health threats by the CDC.
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In its written response, the FDA advised Tetraphase that data from one additional positive phase 3 clinical trial will be required to support a New Drug Application (NDA) submission for IV eravacycline.
Based on the FDA’s response, Tetraphase plans to conduct a pivotal phase 3 clinical trial to evaluate the efficacy and safety of twice-daily IV eravacycline in patients with complicated intra-abdominal infections (cIAI).
The Company expects to provide details regarding the cIAI study design once the protocol is finalized and is anticipating initiation of this cIAI study to take place early in the fourth quarter of 2016. Top-line results from this cIAI study could be available as early as the fourth quarter of 2017. Assuming a positive outcome, data from this study will be used to support the NDA for IV eravacycline as a treatment for patients with cIAI.
In addition, Tetraphase also plans to conduct a phase 3 clinical trial evaluating the efficacy and safety of once-daily IV eravacycline in patients with complicated urinary tract infections (cUTI).
The Company expects to provide details regarding this cUTI study design once the protocol is finalized. Assuming a positive outcome, data from this study will form the basis of a supplemental NDA (sNDA) for IV eravacycline to support treatment in the additional indication of cUTI.
"With a written response from FDA now in hand, we have a confirmed path forward which requires one additional successful phase 3 trial to support an NDA filing for eravacycline," said Guy Macdonald, Tetraphase’s President and Chief Executive Officer.
"We have determined that a trial evaluating IV eravacycline in cIAI provides for the most rapid path to approval, and most importantly, the most rapid path to making eravacycline available to patients. We expect that our existing cash resources are sufficient to fund operations through the data readout for this planned cIAI clinical trial. In parallel, we plan to conduct another phase 3 trial evaluating IV eravacycline in cUTI, and assuming a successful outcome, will use those results to support an sNDA."
Mr. Macdonald continued, "While the time to an NDA filing for eravacycline is longer than we had hoped, our successful phase 3 IGNITE1 study for IV eravacycline in cIAI as well as the promising IV-only efficacy data analysis from the IGNITE2 study in cUTI give us confidence that eravacycline has the potential to become an important option for patients with drug-resistant infections. Our near-term focus for IV eravacycline will be on initiating the additional phase 3 clinical trials in both cIAI and cUTI. Work for both trials is already underway and we look forward to communicating study design details once the clinical trial protocols are finalized."
In addition to the clinical program for IV eravacycline, Tetraphase recently initiated clinical testing designed to advance the oral development program for eravacycline.