The following key attributes of Rravacycline, observed in clinical trials and preclinical studies of Eravacycline, differentiate Eravacycline from other antibiotics targeting multidrug-resistant ( MDR ) infections.

A) Broad-spectrum activity against a wide variety of multi-drug resistant Gram-negative, Gram-positive and anaerobic bacteria. In completed phase 2 clinical trial of the intravenous formulation of Eravacycline, Eravacycline demonstrated a high cure rate against a wide variety of multi-drug resistant Gram-negative, Gram-positive and anaerobic bacteria. In addition, in in vitro studies Eravacycline demonstrated potent antibacterial activity against Gram-negative bacteria, including Escherichia coli; ESBL-producing Klebsiella pneumoniae; Acinetobacter baumannii; Gram-positive bacteria, including MSRA and Vancomycin-resistant enterococcus, or VRE; and anaerobic pathogens. As a result of this broad-spectrum coverage, Eravacycline has the potential to be used as a first-line empiric monotherapy for the treatment of complicated intra-abdominal infections ( cIAI ), complicated urinary tract infections ( cUTI ), hospital-acquired bacterial pneumonias and other serious and life-threatening infections.

B) Favorable safety and tolerability profile. Eravacycline has been evaluated in more than 800 subjects in the Phase 1, Phase 2 and Phase 3 clinical trials that we have conducted. In these trials, Eravacycline has demonstrated a favorable safety and tolerability profile. In the phase 2 and phase 3 clinical trials of Eravacycline in patients with complicated intra-abdominal infections, no patients suffered any drug-related serious adverse events, and safety and tolerability were comparable to Ertapenem, the control therapy in the trials. In addition, in these phase 2 and phase 3 clinical trials, the rate at which gastrointestinal adverse events such as nausea and emesis that occurred in the Eravacycline arms was low.

C) Convenient dosing regimen. In the clinical trials to date, researchers have dosed Eravacycline once or twice a day as a monotherapy. Eravacycline will be able to be administered as a first-line empiric monotherapy with once- or twice-daily dosing, avoiding the need for complicated dosing regimens typical of multi-drug cocktails and the increased risk of negative drug-drug interactions inherent to multi-drug cocktails.

D) Potential for convenient intravenous-to-oral transition therapy. In addition to the IV formulation of Eravacycline, researchers have developed an oral formulation of Eravacycline that they are evaluating in IGNITE 2. If successful, this oral formulation would enable patients who begin IV treatment with Eravacycline in the hospital setting to transition to oral dosing of Eravacycline either in hospital or upon patient discharge for convenient home-based care. The availability of both IV and oral transition therapy may reduce the length of a patient’s hospital stay and the overall cost of care. ( Xagena )

Source: Tetraphase, 2015

XagenaMedicine2015