Spero Therapeutics to Present New Preclinical Data for SPR994 at ASM Microbe 2018

Spero Therapeutics to Present New Preclinical Data for SPR994 at ASM Microbe 2018

June 05, 2018

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 PM3:30 PM, Lounge and Learn 2, Building A, Level 3, Session 150, Presenter: L. McEntee
    Poster 233, Saturday June 9, 2018, 11:00 AM1:00 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 PM2:45 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 PM2:45 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 PM2:45 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 PM2:45 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 PM2:45 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 PM2:45 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 PM2:45 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 PM2:45 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 PM2:45 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 PM2:45 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 PM2:45 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 PM2:45 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 PM3:15 PM, Lounge and Learn 2, Building A, Level 3, Session 150, Presenter: A. Rubio
    Poster 539, Sunday June 10, 2018, 12:45 PM2:45 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 PM2:45 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 PM2:45 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 AM1 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 AM1 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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Source: Spero Therapeutics, Inc.