"We are pleased with the positive safety, tolerability and pharmacokinetic data from these first-in-human studies for both of our novel pipeline candidates and we are continuing to advance them through phase 1," said
Safety, Tolerability and Pharmacokinetics of Single Doses of TP-6076, a Novel Fully Synthetic Tetracycline
This oral presentation highlighted data from a phase 1 randomized, placebo-controlled, double-blind, single-ascending dose study evaluating the safety, tolerability and pharmacokinetics of IV TP-6076. The study was conducted at a single center in 40 healthy volunteers. Five sequential cohorts were randomized 6:2 to receive single doses ranging from 1.8 mg up to 60 mg, or placebo.
In this study, TP-6076 was well tolerated and there were no serious or severe adverse events, or discontinuations due to an adverse event. There were no clinically significant safety findings in any laboratory assessments, vital signs, ECGs or physical examinations. The most frequently reported adverse events in the TP-6076 groups were gastrointestinal, which consisted primarily of nausea in the highest dose group, no vomiting was reported. Following single IV doses of TP-6076, exposure to TP-6076 increased in a slightly greater than dose proportional manner.
TP-6076 is a novel, synthetic, fluorocycline antibiotic candidate being developed for the treatment of serious and life-threatening bacterial infections, including those caused by pathogens otherwise resistant to current treatment options. It has demonstrated potent in vitro activity against multidrug-resistant bacteria including carbapenem-resistant Enterobacteriaceae and carbapenem-resistant Acinetobacter baumannii.
Safety, Tolerability and Pharmacokinetics of Single Intravenous Doses of TP-271, a Novel Fluorocycline Antibiotic
This poster presentation described data from a phase 1 randomized, double-blind, placebo-controlled, single-ascending-dose, single-center study evaluating the safety, tolerability and pharmacokinetics of IV TP-271. The study was conducted at a single center in 56 healthy volunteers. Seven cohorts of 8 subjects each were randomized 6:2 to receive single doses ranging from 0.15 mg/kg up to 5 mg/kg, or placebo.
TP-271 was well tolerated at single doses that resulted in high plasma exposures. There were no clinically significant changes in lab values, ECG parameters, or physical exam findings. There were no serious or severe adverse events, or discontinuations due to an adverse event during the study. The most frequently reported adverse events in the TP-271 groups were gastrointestinal, which consisted of nausea and vomiting occurring mostly in the highest dose group. Following single IV doses of TP-271, plasma exposures increased as dose increased in a greater than dose-proportional manner.
TP-271 is a novel, broad-spectrum antibiotic candidate which is being developed to combat respiratory disease caused by bacterial biothreats and antibiotic-resistant public health pathogens, including Francisella tularensis, Yersinia pestis and Bacillus anthracis, as well as bacterial pathogens associated with
community-acquired bacterial pneumonia. Tetraphase is developing TP-271 with funding from the
ASM Microbe 2017 is the integration of two of the
About Tetraphase Pharmaceuticals, Inc.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening bacterial infections, including those caused by many of the multidrug-resistant (MDR) bacteria highlighted as urgent public health threats by the
Tetraphase Pharmaceuticals Teri Dahlman617-600-7040 firstname.lastname@example.org Argot Partners Maeve Conneighton206.899.4940 email@example.com Media Contact: Sam Brown Inc. Mike Beyer312-961-2502 Mikebeyer@sambrown.com
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