Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset
clinical-stage biopharmaceutical company focused on identifying,
developing and commercializing treatments in high unmet need areas
involving multi-drug resistant (MDR) bacterial infections and rare
diseases, today announced that it will present four posters at
the Infectious Disease Society of America (IDSA)
IDWeek™ 2019 taking place October 2 - 6,
2019 in Washington, DC. Presentations include one
poster on the pharmacokinetics-pharmacodynamics of SPR994, Spero’s
oral carbapenem antibiotic product candidate currently in a Pivotal
Phase 3 clinical trial for the treatment of complicated urinary
tract infections (cUTI), and three posters on cUTI epidemiology and
antimicrobial susceptibility.
Title: Characterization of
Tebipenem (SPR859) Pharmacokinetics- Pharmacodynamics (PK-PD) for
Efficacy Against Enterobacteriaceae in a One-Compartment In Vitro
Infection ModelPresenter: Brian
VanScoyDate and Time: Friday, October 4th, 2019;
12:15 – 1:30 PM ETLocation: Halls B and
CAbstract Number: 1565
Title: Resistance to Oral Antibiotics among
Urinary Tract Infection Isolates of Escherichia coli from the
United States and Europe in 2017Presenter: Ian
CritchleyDate and Time: Friday, October 4th, 2019;
12:15 – 1:30 PM ETLocation: Halls B and
CAbstract Number: 1465
Title: Antimicrobial Susceptibility Patterns of
Common Complicated Urinary Tract InfectionPathogens in US
Hospitals, 2013-2018Presenter: Marya
ZilberbergDate and Time: Friday, October 4th,
2019; 12:15 – 1:30 PM ETLocation: Halls B and
CAbstract Number: 1461
Title: Epidemiology, Empiric Treatment, and
Outcomes Among Hospitalized Patients with Complicated Urinary Tract
Infections in the US, 2013-2018Presenter: Marya
ZilberbergDate and Time: Friday, October 4th,
2019; 12:15 – 1:30 PM ETLocation: Halls B
and CAbstract Number: 1455
Abstracts are accessible via the IDWeek™
website. The poster presentation may be accessed through Spero
Therapeutics’ website on the “Key Publications and
Presentations” page under the “Pipeline” tab following its
presentation.
SPR994 Research SupportThis
project has been funded in part with Federal funds from
the Department of Health and Human Services; Office of
the Assistant Secretary for Preparedness and
Response; Biomedical Advanced Research and Development
Authority, under Contract No. HHSO100201800015C.
About SPR994SPR994 is Spero’s
novel investigational oral formulation of tebipenem, a
carbapenem-class antibiotic marketed by Meiji Seika Pharma Co.
Ltd. (Meiji) in Japan as Orapenem® since 2009 for
pediatric infections limited to pneumonia, otitis media and
sinusitis. Carbapenems are an important class of antibiotics
because they have been demonstrated to be safe and effective
against drug-resistant Gram-negative bacterial
infections. Spero is currently enrolling patients into its
pivotal Phase 3 clinical trial of SPR994 entitled ADAPT-PO [A Phase
3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective
Study to Assess the Efficacy, Safety and Pharmacokinetics
of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994)
Compared to Intravenous Ertapenem in Patients with Complicated
Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)].
SPR994 has been granted Qualified Infectious Disease Product (QIDP)
and Fast Track designations by the FDA.
About SperoSpero Therapeutics, Inc. is a
multi-asset, clinical-stage biopharmaceutical company focused on
identifying, developing and commercializing novel treatments for
multidrug-resistant (MDR) bacterial infections and rare
diseases.
Spero’s lead product candidate, SPR994, is
designed to be the first oral carbapenem-class antibiotic for use
in adults to treat MDR Gram-negative infections.
Spero is also advancing SPR720, its novel oral
therapy product candidate designed for the treatment of rare,
orphan disease caused by pulmonary non-tuberculous mycobacterial
(NTM) infections.
Spero also has a platform technology known as
its Potentiator Platform that it believes will enable it to develop
drugs that will expand the spectrum and potency of existing
antibiotics, including formerly inactive antibiotics, against
Gram-negative bacteria. Spero’s lead product candidates generated
from its Potentiator Platform are two IV-administered agents,
SPR206 and SPR741, designed to treat MDR Gram-negative infections
in the hospital setting.
Forward Looking Statements
This press release may contain forward-looking
statements. These statements include, but are not limited to,
statements about Spero’s expectation that positive results from a
single pivotal Phase 3 clinical trial of SPR994 and ancillary
supportive studies to be conducted in parallel with the Phase 3
trial will support the approval of SPR994; the initiation, timing,
progress and results of Spero’s preclinical studies and clinical
trials and its research and development programs; statements
regarding management’s assessment of the results of such
preclinical studies and clinical trials; the timing of clinical
data, including the availability of pharmacokinetic data from the
lead-in cohort in the Phase 3 clinical trial of SPR994 and top-line
data from the Phase 1 clinical trial of SPR720 and the Phase 1
clinical trial of SPR206; and Spero’s cash forecast and anticipated
expenses, the sufficiency of its cash resources and the
availability of additional non-dilutive funding from governmental
agencies beyond any initially funded awards. In some cases,
forward-looking statements can be identified by terms such as
“may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,”
“could,” “intent,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the negative of
these terms or other similar expressions. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including whether
the FDA will accept a single pivotal study for approval
of SPR994; whether results obtained in preclinical studies and
clinical trials will be indicative of results obtained in future
clinical trials; whether Spero’s product candidates will advance
through the preclinical development and clinical trial process on a
timely basis, or at all, taking into account the effects of
possible regulatory delays, slower than anticipated patient
enrollment, manufacturing challenges, clinical trial design and
clinical outcomes; whether the results of such trials will warrant
submission for approval from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies;
whether Spero’s cash resources will be sufficient to fund its
continuing operations for the periods and/or trials anticipated;
and other factors discussed in the “Risk Factors” set forth in
filings that Spero periodically makes with the U.S. Securities
Exchange Commission. The forward-looking statements included in
this press release represent Spero’s views as of the date of this
press release. Spero anticipates that subsequent events and
developments will cause its views to change. However, while Spero
may elect to update these forward-looking statements at some point
in the future, it specifically disclaims any obligation to do so.
These forward-looking statements should not be relied upon as
representing Spero’s views as of any date subsequent to the date of
this press release.
Spero Investor and Media Contact: Sharon Klahre
Senior Director, Investor Relations 857-242-1547
IR@sperotherapeutics.com
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