Data presented by Tetraphase Pharmaceuticals at IDWeek confirmed that the timing of oral dosing relative to meals drove the lower than expected drug exposures seen with the oral dosing regimen in IGNITE2.
These results, presented at IDWeek 2017, helped identify an optimized IV-to-oral dosing regimen using the current oral formulation which the company plans to move to the second phase in patients with complicated urinary tract infections (cUTI). The study is expected to begin in the first half of 2018.
Eravacycline is a fully-synthetic fluorocycline antibiotic made to treatment serious infections, including those caused by MDR pathogens.
Guy Macdonald, President and Chief Executive Officer of Tetraphase is encouraged by the clinical data in healthy volunteers seen in the phase 1 oral eravacycline development program. He said the company is waiting to begin the next step of testing the optimized IV-to-oral dosing regimen in a patient population.
He said that, in addition to establishing an oral dosing regimen, this phase 1 program has also confirmed that drug exposures and urine concentrations achieved with IV eravacycline are within the expected therapeutic range and support the efficacy of once-daily IV eravacycline in cUTI, which we are evaluating in the ongoing phase 3 IGNITE3 study. „We look forward to topline data for IGNITE3 in the first quarter of 2018,” he said.
Patrick Horn, Chief Medical Officer of Tetraphase noted that the data presented at IDWeek confirm that the timing of oral dosing relative to meals drove the lower than expected drug exposures seen with the oral dosing regimen in IGNITE2. That was the first phase 3 IV-to-oral study in cUTI. He said that the subsequent studies in this phase 1 oral program then evaluated different doses of eravacycline and varied meal time/dosing schedules.
Horn said: “Results confirmed that increasing the interval between meals and dosing and administering a 250 mg oral dose of eravacycline produces drug exposures that we believe will be therapeutic in cUTI. With this optimized IV-to-oral dosing regimen, drug exposures achieved with the oral dose were 81% of those achieved with IV dosing, approximately double the exposure observed with the dosing regimen used in IGNITE2.”