Entasis Therapeutics Announces Initial ETX0282 Phase 1 Results
June 13 2019 - 8:00AM
Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage
biopharmaceutical company developing novel antibacterials to treat
serious drug-resistant infections, today reported initial
preliminary results from the first-in-human Phase 1 clinical trial
of its novel, oral beta-lactamase inhibitor ETX0282. The Phase 1
trial is evaluating the safety, tolerability and pharmacokinetics
of ETX0282 either alone or in combination with cefpodoxime
proxetil, ETX0282CPDP, in healthy volunteers. The Company is
developing ETX0282CPDP as an oral therapy for infections caused by
multidrug-resistant (MDR) Gram-negative pathogens, including
ESBL-producing and carbapenem-resistant Enterobacteriaceae.
This Phase 1 clinical trial (NCT03491748) is a
randomized, double-blind, placebo-controlled study of ETX0282 in
healthy subjects and consists of several parts including:
single-ascending dose, multiple-ascending dose, effect of food on
absorption, and assessment of drug-drug interaction between ETX0282
and cefpodoxime proxetil. The trial has currently enrolled 79
healthy subjects with 61 subjects having received at least one oral
dose of ETX0282 between 100mg – 800mg. In the Phase 1 trial,
ETX0282 in a “powder in capsule” formulation was rapidly absorbed,
and plasma concentrations of the beta-lactamase inhibitor were in
the projected therapeutic range. There was no drug-drug interaction
between ETX0282 and cefpodoxime proxetil. When administered with a
high fat meal, ETX0282 demonstrated similar overall exposures as
compared to fasting subjects, but with a modified pharmacokinetic
profile including decreased peak concentrations. ETX0282 was
generally well tolerated either alone or in combination with
cefpodoxime proxetil, with no serious adverse events reported.
While eight subjects reported mild-to-moderate, transient emesis
(vomiting), none of the volunteers who received ETX0282 with a high
fat meal reported emesis. Additional studies are planned to further
investigate the potential correlation between absorption profile
and emesis and to formulate ETX0282 for further clinical
development.
“These preliminary Phase 1 data support the
ongoing development of ETX0282CPDP as a potential oral treatment
for patients with Gram-negative infections caused by MDR
Enterobacteriaceae,” said Robin Isaacs, MD, Chief Medical Officer
of Entasis. “We believe there are meaningful benefits to both the
patient and the hospital to enable oral treatment of MDR
Gram-negative infections and there are currently limited treatment
options available. With its ability to provide broad coverage of
MDR Enterobacteriaceae, ETX0282CPDP has the potential to become a
best-in-class oral therapeutic option for treatment of such
infections. We look forward to continuing the development of
ETX0282CPDP as a treatment option for this growing medical
need.”
About ETX0282CPDP ETX0282 is an
orally available, broad spectrum inhibitor of Class A and C
beta-lactamases. Entasis is developing ETX0282 in combination with
cefpodoxime proxetil, an orally available cephalosporin approved
for treatment of a variety of bacterial infections. Cefpodoxime
proxetil’s clinical utility is currently limited by
beta-lactamase-mediated resistance. In preclinical studies, ETX0282
restored cefpodoxime proxetil’s antimicrobial activity against a
variety of pathogens, including Enterobacteriaceae resistant to
fluoroquinolones, cephalosporins and carbapenems. ETX0282CPDP, the
combination of ETX0282 and cefpodoxime proxetil, is being developed
for the treatment of infections caused by Enterobacteriaceae,
including multidrug-resistant and carbapenem-resistant
Enterobacteriaceae (CRE). The ETX0282CPDP program is partially
supported by an award from CARB-X.
About EntasisEntasis is a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of novel antibacterial products
to treat serious infections caused by multidrug-resistant
Gram-negative bacteria. Entasis’ targeted-design platform has
produced a pipeline of product candidates, including ETX2514SUL
(targeting A. baumannii infections), zoliflodacin (targeting
Neisseria gonorrhoeae), and ETX0282CPDP (targeting
Enterobacteriaceae infections). Entasis is also using its platform
to develop a novel class of antibiotics, non-β-lactam inhibitors of
the penicillin-binding proteins (NBPs) (targeting Gram-negative
infections). For more information, visit www.entasistx.com.
ETX0282 Research Support
Research reported in this press release is
supported by the Cooperative Agreement Number IDSEP160030 from
ASPR/BARDA and by an award from Wellcome Trust, as administrated by
CARB-X. The content is solely the responsibility of the authors and
does not necessarily represent the official views of the U.S.
Department of Health and Human Services Office of the
Assistant Secretary for Preparedness and Response, other
funders, or CARB-X.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are based on Entasis’ expectations
and assumptions as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties. Actual
results may differ materially from these forward-looking
statements. Forward-looking statements contained in this press
release include statements about the continued development,
progress, and scope of the Phase 1 clinical trial of ETX0282. Many
factors may cause differences between current expectations and
actual results, including unexpected safety or efficacy data
observed during non-clinical or clinical studies, clinical site
activation rates or clinical trial enrollment rates that are lower
than expected and changes in expected or existing competition.
Other factors that could adversely affect Entasis’ business and
prospects are described under the “Risk Factors” section in its
filings with the Securities and Exchange Commission (“SEC”).
Entasis’ SEC filings are available for free by visiting the
investor section of its website, www.entasistx.com, or the SEC’s
website, www.sec.gov. Except as required by law, Entasis
assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new
information becomes available.
Entasis Company Contact Kyle Dow Entasis
Therapeutics (781) 810-0114 kyle.dow@entasistx.com
Investor Relations Contacts Tram Bui / Janhavi
Mohite The Ruth Group (646) 536-7035 / 7026 tbui@theruthgroup.com
jmohite@theruthgroup.com
Media ContactKirsten ThomasThe Ruth Group(508)
280-6592kthomas@theruthgroup.com
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