TETRAPHASE PHARMACEUTICALS, INC.
Our Business
We are a clinical-stage
biopharmaceutical company using our proprietary chemistry technology to create novel antibiotics for serious and life-threatening multidrug-resistant infections. We are developing our lead product candidate, eravacycline, a fully-synthetic
fluorocycline, as an intravenous, or IV, and oral antibiotic for use as a first-line empiric monotherapy for the treatment of multidrug-resistant infections, including multidrug-resistant, or MDR, Gram-negative infections.
We are conducting a global phase 3 clinical program for eravacycline called IGNITE (Investigating
Gram-Negative Infections Treated with Eravacycline). We are also pursuing the discovery and development of additional antibiotics that target unmet medical needs, including multidrug-resistant Gram-negative
bacteria.
On July 25, 2017, we announced top-line data from our IGNITE4 trial, a global
phase 3 randomized, double-blind, double-dummy, multicenter, prospective study assessing the efficacy, safety and pharmacokinetics of twice-daily IV eravacycline (1.0 mg/kg every 12 hours) compared with meropenem (1g every
8 hours) for the treatment of complicated intra-abdominal infections, or cIAI, that we conducted in 500 patients. In the trial, eravacycline met the primary endpoint of statistical non-inferiority of
clinical response at the test-of-cure, or TOC, visit, under the guidance set by the United States Food and Drug Administration, or FDA, and the European Medicines
Agency, or EMA. Prior to IGNITE 4, we conducted IGNITE1, a phase 3 clinical trial of twice daily IV eravacycline (1.0 mg/kg every 12 hours) compared with ertapenem (1.0g IV every 24 hours) for the treatment of cIAI. In
IGNITE1, eravacycline met the primary endpoint of statistical non-inferiority of clinical response.
In January 2018, we announced the submission of a new drug application, or NDA, for eravacycline for the treatment of cIAI with the FDA based
on the positive results observed in both IGNITE1 and IGNITE4. In the third quarter of 2017 we submitted a marketing authorization application, or MAA, to the EMA for IV eravacycline for the treatment of cIAI primarily based upon the
results of IGNITE1.
We are also developing eravacycline for the treatment of complicated urinary tract infections, or cUTI. In January
2017, we initiated IGNITE3, a randomized, multi-center, double-blind, phase 3 clinical trial evaluating the efficacy and safety of once-daily IV eravacycline compared to ertapenem, the control therapy in this trial, for the treatment of
cUTI. We completed enrollment in IGNITE3 in September 2017 and expect to report top-line data from this trial in the first quarter of 2018. If IGNITE3 is successful, we plan to use the results from IGNITE3 to
support submission of a supplemental new drug application, or sNDA, for IV eravacycline for the treatment of cUTI, assuming approval first of IV eravacycline for the treatment of cIAI.
In parallel with the clinical trials using IV eravacycline, we are continuing our development program for an oral formulation of
eravacycline. We have identified an optimized IV-to-oral dosing regimen using the current oral formulation which we plan to advance into a phase 2 clinical trial in
patients with cUTI.
The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for IV and oral
eravacycline for cIAI and cUTI.
In June 2017, we announced positive results from a phase 1 single-ascending dose clinical trial of the IV
formulation of TP-271, a fully-synthetic fluorocycline being developed for respiratory disease caused by bacterial biothreat pathogens, in healthy volunteers. We are conducting a multiple-ascending dose trial
for the IV formulation of TP-271. We also plan to initiate a multiple-ascending dose phase 1 study for the oral formulation of TP-271 in early 2018. In February 2017, we
received Qualified Infectious Disease Product and Fast Track designations from the FDA.
In addition, we
are developing TP-6076, a fully-synthetic fluorocycline derivative, as a lead candidate under our second-generation program to target unmet medical needs, including multidrug-resistant Gram-negative
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