TP-271, the project that just entered clinical testing.....
Tetraphase Pharmaceuticals Initiates Phase 1 Clinical Trial for TP-271
First Human Patient Dosed in Trial Evaluating Novel Antibiotic Candidate Being Developed for Bacterial Respiratory Infections With Support From National Institute of Allergy and Infectious Diseases
WATERTOWN, Mass., Jan. 19, 2016 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today announced the initiation of patient dosing in a phase 1 clinical trial for intravenous (IV) TP-271, 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.
"The initiation of this first-in-man phase 1 study for TP-271 demonstrates continued progress with the Company's pipeline of novel antibiotic candidates," said Patrick Horn, Chief Medical Officer of Tetraphase. "With preclinical data supporting its activity against a broad-spectrum of bacterial pathogens, we look forward to evaluating TP-271 in the clinic."
The trial is a randomized, double-blind, placebo-controlled, single-ascending-dose (SAD), single-center study in up to 56 healthy volunteers. This is the first study in a phase 1 clinical program which is also expected to include a multiple-ascending dose (MAD) study for IV TP-271 followed by SAD and MAD studies for oral TP-271. In September 2015, TP-271 received Qualified Infectious Disease Product and Fast Track designations from the FDA for the treatment of community-acquired bacterial pneumonia.
Tetraphase is developing TP-271 with funding from the National Institutes of Health's National Institute of Allergy and Infectious Diseases, which supports preclinical development, manufacturing and phase 1 clinical, safety and pharmacokinetic evaluation of TP-271. In preclinical studies, TP-271 has demonstrated potency against Gram-negative and Gram-positive pathogens associated with respiratory tract infections.
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ncbi.nlm.nih.gov
Antimicrob Agents Chemother. 2012 Jul; 56(7): 3986–3988.
In Vitro Activity of TP-271 against Mycobacterium abscessus, Mycobacterium fortuitum, and Nocardia Species
Michael Cynamon,a Jeff Jureller,a Balaji Desai,a Krithika Ramachandran,a Mary Sklaney,a and Trudy H. Grossmanb
aVAMC, Syracuse, New York, USA
bTetraphase Pharmaceuticals, Inc., Watertown, Massachusetts, USA
The in vitro activities of TP-271, a novel fluorocycline antimicrobial, against 22 isolates of Mycobacterium abscessus, 22 isolates of Mycobacterium fortuitum, and 19 isolates of Nocardia spp. were studied by a microtiter broth dilution method. The MIC90s for M. abscessus, M. fortuitum, and Nocardia spp. were 0.5 µg/ml, 0.03 µg/ml, and 8 µg/ml, respectively. TP-271 was significantly more active than the respective control drug in virtually all tests. |
