Eighteen presentations with data across multiple pipeline candidates including data supporting SPR994’s broad spectrum of
activity and equivalence to IV carbapenems
CAMBRIDGE, Mass., June 05, 2018 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset
clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for
multidrug-resistant (MDR) bacterial infections, announced today that it will present two oral presentations and eighteen poster
presentations across substantially all of Spero’s pipeline drug candidates at the American Society of Microbiology (ASM) Microbe
2018 Conference taking place June 7 - 11, 2018 in Atlanta, Georgia.
Data to be presented at ASM Microbe 2018 for SPR994, Spero’s oral carbapenem, will highlight observations
regarding its in vitro activity and potency against fluoroquinolone-resistant organisms and bacteria harboring
extended-spectrum beta-lactamase (ESBLs) enzymes, for which there is a significant and growing unmet need for new therapies. The
presentations will also include in vitro data supporting SPR994’s equivalent potency to IV carbapenems, the gold standard
for the treatment of ESBL infections, against the most common Gram-negative bacteria encountered in complicated urinary tract
infections (cUTI).
Data to be presented on SPR720, Spero’s novel oral product candidate for the treatment of non-tuberculous
mycobacterial (NTM) infections, will highlight observations regarding its potency and broad spectrum in vitro and in
vivo activity against the most common and difficult-to-treat NTM pathogens, including Mycobacterium abscessus and
Mycobacterium avium.
Data to be presented on SPR741, Spero’s IV-administered clinical candidate for MDR Gram-negative infections in
the hospital setting, will build on results presented at the European Congress of Clinical Microbiology and Infectious
Diseases (ECCMID) Conference in April 2018, and include data on the potent, broad-spectrum activity of SPR741 when
co-administered with both Gram-positive and Gram-negative antibiotics in vitro and in preclinical mouse infection
models.
“We are encouraged by the data we have observed across our pipeline spanning from our oral product candidate,
SPR994, under development to treat resistant Gram-negative infections, to SPR720, our oral product candidate under development to
treat NTM, and SPR741, our IV potentiator candidate to treat MDR infections in the hospital,” said Ankit Mahadevia, M.D., CEO of
Spero Therapeutics. “We are especially excited to present data for the first time on SPR994, our oral carbapenem, and its potency
versus ESBL-producing and fluoroquinolone-resistant bacteria, growing problems for which there are limited oral treatment
options. We remain committed to aligning our pipeline to good stewardship principles by targeting populations with the
greatest unmet medical need and where generic options are not viable.”
Presentations pertaining to SPR994, Spero’s broad-spectrum oral carbapenem antibiotic product candidate
currently in Phase 1 SAD/MAD trials are below. SPR859 is the microbiologically active metabolite of SPR994, which is formulated as
a prodrug, specifically tebipenem pivoxil.
- Pharmacokinetics and Pharmacodynamics of Tebipenem for Multi-drug Resistant Enterobacteriaceae
Presentation 7, Friday June 8, 2018, 3:25 PM – 3:30 PM, Lounge and Learn 2, Building A, Level 3, Session 150,
Presenter: L. McEntee
Poster 233, Saturday June 9, 2018, 11:00 AM – 1:00 PM, Building B, Halls B2-B5, Session 233 - AAR04, Presenter: L. McEntee
- In Vitro Activity of Tebipenem (SPR859) against Penicillin-Binding Proteins of
Gram-Negative Bacteria
Poster 556, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter: É.
Lacasse
- Characterization of the Mechanism of Action of Tebipenem (SPR859) in the Escherichia
coli Macromolecular Synthesis Assay
Poster 557, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter: D.
Shinabarger
- Antimicrobial Activity of Tebipenem (SPR859) against A Global Challenge Set of
Enterobacteriaceae Isolates
Poster 558, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter: R. E.
Mendes
- In Vitro Activity of Tebipenem (SPR859), Tebipenem-Pivoxil (SPR994) and Meropenem against A
Broad Spectrum of Anaerobic Bacteria
Poster 559, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter: A.
Rubio
- Antimicrobial Activity Assessment of Tebipenem (SPR859) against An Isolate Collection Causing Urinary Tract
Infections
Poster 560, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter: R. E.
Mendes
- In Vitro Bactericidal Activity and Post-Antibiotic Effect of Tebipenem (SPR859) against
Susceptible and Extended-Spectrum Beta-Lactamase Producing Enterobacteriaceae as Compared to Levofloxacin (LVX) and Meropenem
(MEM)
Poster 561, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter: N.
Cotroneo
- The Impact of Varied Test Conditions on the In Vitro Activity of Tebipenem
(SPR859) and Meropenem against Urinary Pathogens, Including Those Expressing Extended-Spectrum Beta-Lactamases (ESBL)
Poster 562, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter: C.
Pillar
- Frequency of Spontaneous Mutations Conferring Reduced Susceptibility to Tebipenem (SPR859) among Susceptible and
Extended-Spectrum Beta-Lactamase Producing Escherichia coli and
Klebsiella Pneumoniae
Poster 563, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter:
N. Cotroneo
- Dose Ranging and Dose Fractionation of Tebipenem-Pivoxil (SPR994) in Neutropenic Murine Thigh Models of Gram-Negative
Bacterial Infection
Poster 564, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter: P.
Warn
- In Vivo Characterization of Tebipenem-Pivoxil (SPR994) in A Murine Ascending
Escherichia coli Urinary Tract Infection Model
Poster 565, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter: K.
Heang
- In Vivo Efficacy of Tebipenem-Pivoxil (SPR994) in An Acute Murine Thigh Infection Caused
by Escherichia coli And Klebsiella pneumoniae
Poster 566, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter:
L. Grosser
- In Vivo Efficacy of Tebipenem-Pivoxil (SPR994) in Neutropenic Murine Lung Models of
Gram-Negative Bacterial Infection
Poster 567, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 412 - AAR08, Presenter: P.
Warn
Presentations pertaining to SPR720, Spero’s novel investigational oral gyrase inhibitor designed for the
treatment of NTM infections and currently completing IND-enabling studies, are below.
- Potent Activity of a Novel Gyrase Inhibitor (SPR719/SPR720) In Vitro And
in A Prolonged Acute Mycobacterium Abscessus Mouse Model of Infection
Presentation 4, Friday June 8, 2018, 3:10 PM – 3:15 PM, Lounge and Learn 2, Building A, Level 3, Session 150,
Presenter: A. Rubio
Poster 539, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 411 - AAR08, Presenter: A. Rubio
- In Vitro Characterization of A Novel Gyrase Inhibitor (SPR719) against Nontuberculous
Mycobacteria
Poster 538, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 411 - AAR08, Presenter: B.
Brown-Elliott
- Treatment of Mycobacterium Avium Subspecies
Hominissuis (MAH) Infection with A Novel Gyrase Inhibitor (SPR719/SPR720) Was Associated with A
Significant Decrease in Bacterial Load As Assessed in Macrophages, Biofilm and in Mice
Poster 540, Sunday June 10, 2018, 12:45 PM – 2:45 PM, Building B, Halls B2-B5, Session 411 - AAR08, Presenter: A.
Rubio
Presentations pertaining to SPR741, Spero’s first clinical candidate from our Potentiator Platform that recently
completed positive Phase 1a and Phase 1b trials and is under development to treat MDR Gram-negative infections in the hospital
setting, are below.
- Assessment of the In Vivo Efficacy of SPR741 in Combination with
Azithromycin (Azm) against Multidrug (Mdr) Resistant Enterobacteriaceae (Eb) Isolates
in the Neutropenic Murine Thigh Infection Model
Poster 561, Saturday June 9, 2018, 11 AM – 1 PM CDT, Building B, Halls B2-B5, Session 233 - AAR04, Presenter: S. M.
Stainton
- A Pharmacokinetics-Pharmacodynamic Evaluation of the Novel Antibiotic Potentiator, SPR741, in Combination with
Piperacillin/Tazobactam against Enterobacteriaceae
Poster 594, Saturday June 9, 2018, 11 AM – 1 PM CDT, Building B, Halls B2-B5, Session 235 - AAR08, Presenter: B. D.
VanScoy
The complete abstracts for the presentations listed above can be accessed through the ASM Microbe website.
About Spero
Spero Therapeutics is a multi-asset, clinical-stage biopharmaceutical company focused on identifying,
developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections.
The Company’s lead product candidate, SPR994, is designed to be the first broad-spectrum oral carbapenem-class
antibiotic for use in adults to treat MDR Gram-negative infections.
The Company 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. The Company’s lead product candidates generated from its Potentiator Platform are two intravenous, or
IV,-administered agents, SPR741 and SPR206, designed to treat MDR Gram-negative infections in the hospital setting.
Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of pulmonary
non-tuberculous mycobacterial (NTM) infection.
For more information, visit https://sperotherapeutics.com.
SPR741 Research Support
The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the
awarding and administering acquisition office. This work was supported by the Office of the Assistant Secretary of Defense for
Health Affairs, through the Peer Reviewed Medical Research Program under Award No. W81XWH-16-2-0019. Opinions, interpretations,
conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. In
conducting research using animals, the investigator(s) adheres to the laws of the United States and regulations of the Department
of Agriculture.
This work is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from
Wellcome Trust, as administrated by CARB-X (subaward 4500002328). The contents are solely the responsibility of the authors and do
not necessarily represent the official views of CARB-X, the HHS Office of the Assistant Secretary for Preparedness and
Response, the National Institutes of Health or Wellcome Trust.
Forward Looking Statements
This press release may contain forward-looking statements. These statements include, but are not limited
to, statements about the initiation, timing, progress and results of the Company’s preclinical studies and clinical trials and the
Company’s research and development programs, including statements regarding management’s assessment of the results of such
preclinical studies and clinical trials, the timing of clinical data, the Company’s cash forecast and anticipated expenses and the
sufficiency of the Company’s cash resources. 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 results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical
trials; whether the Company’s product candidates will advance through the preclinical development and clinical trial process on a
timely basis, or at all; whether the results of such trials will warrant submission for approval from the United States Food
and Drug Administration or equivalent foreign regulatory agencies; whether the Company’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 we periodically make with the U.S. Securities Exchange Commission. The forward-looking statements
included in this press release represent the Company’s views as of the date of this press release. The Company anticipates
that subsequent events and developments will cause its views to change. However, while the Company 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 the Company’s views as of any date subsequent to the date of
this press release.
Spero Investor Contact:
Sharon Klahre
Director, Investor Relations
857-242-1547
IR@sperotherapeutics.com
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