Tetraphase Pharmaceuticals Announces Positive Phase 1 Single-Ascending Dose Data for Antibiotic Pipeline Candidates
June 05 2017 - 8:00AM
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage
biopharmaceutical company developing novel antibiotics to treat
life-threatening multidrug-resistant (MDR) infections, today
announced positive data from phase 1 single-ascending dose studies
for its two pipeline programs, TP-6076 and TP-271. These data were
presented at the American Society for Microbiology (ASM) Microbe
2017 Annual Meeting, held June 1-5, 2017 in New Orleans, LA.
“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 Guy Macdonald, President and Chief Executive
Officer of Tetraphase. “We recently initiated a multiple-ascending
dose (MAD) study evaluating a 7-day dosing regimen for intravenous
(IV) TP-6076 in healthy volunteers and we are on track to initiate
a MAD study evaluating a 7-day dosing regimen for IV TP-271 in
healthy volunteers during 2017. We are also evaluating an oral
formulation of TP-271, which is currently in a single-ascending
dose study.”
Mr. Macdonald added, “Additional data presented at ASM Microbe
on these two compounds confirm potent preclinical activity seen
previously, particularly against Gram-negative pathogens. For
TP-6076, the MIC90 values reported were as much as 64-fold lower
than those for tigecycline against MDR Gram-negative pathogens,
including carbapenem-resistant Enterobacteriaceae and Acinetobacter
baumannii. For TP-271, two in vivo studies were presented showing
efficacy of TP-271 supporting its potential use in respiratory
infections caused by Acinetobacter baumannii as well as its use as
a countermeasure for the treatment of inhalation anthrax.”
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 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.
ASM Microbe 2017 is the integration of two of the American
Society of Microbiology’s meetings: the General Meeting and
ICAAC (Interscience Conference on Antimicrobial Agents and
Chemotherapy). Requests for presentations can be sent to Medical
Affairs through the Tetraphase website at
https://www.tphase.com/our-science/clinical-programs/.
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 CDC.
Tetraphase has created more than 3,000 novel tetracycline analogs
using its proprietary technology platform. Tetraphase's pipeline
includes three antibiotic clinical candidates: eravacycline, which
is in phase 3 clinical trials, and TP-271 and TP-6076, which are in
phase 1 clinical trials. Please visit www.tphase.com for more
company information.
Investor Contacts:
Tetraphase Pharmaceuticals
Teri Dahlman
617-600-7040
tdahlman@tphase.com
Argot Partners
Maeve Conneighton
206.899.4940
maeve@argotpartners.com
Media Contact:
Sam Brown Inc.
Mike Beyer
312-961-2502
Mikebeyer@sambrown.com
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