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Spero Therapeutics to Present New Data for SPR994 and SPR206 at ESCMID/ASM 2018 Conference

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Highlights include eleven presentations covering SPR994's pharmacokinetics and pharmacodynamics, SPR206's broad spectrum of activity and favorable toxicology, and urinary tract infection epidemiology

CAMBRIDGE, Mass., Aug. 28, 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 bacterial infections, announced today that it will present one oral presentation and ten poster presentations related to Spero's pipeline drug candidates SPR994 and SPR206 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID)/American Society for Microbiology (ASM) Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance taking place September 4 - 7, 2018 in Lisbon, Portugal.

Pharmacokinetic and pharmacodynamic data for SPR994, Spero's oral carbapenem product candidate, in both the neutropenic mouse thigh infection model and the hollow fiber infection model will be featured at ESCMID/ASM 2018.  The findings from these studies have played an important role in identifying an optimal dosing regimen of SPR994 in patients with complicated urinary tract infections (cUTI) by linking drug exposure to antibiotic activity.  These data, in conjunction with the interim SPR994 Phase 1 SAD/MAD data announced in June 2018, support the advancement of SPR994 into a planned pivotal Phase 3 clinical trial around year-end 2018 for the treatment of cUTI.  Spero continues to expect to report final SPR994 Phase 1 SAD/MAD data in the third quarter of 2018. 

SPR206, one of the molecules within Spero's Potentiator Platform, is designed as a single agent to treat multidrug resistant (MDR) and extensively drug-resistant (XDR) bacterial strains, including carbapenem-resistant Pseudomonas aeruginosaAcinetobacter baumannii, and Enterobacteriaceae, for which there is a significant unmet medical need.  Data from non-clinical, IND-enabling studies of SPR206 will be presented at ESCMID/ASM 2018 that collectively demonstrate SPR206's broad antimicrobial spectrum and favorable safety profile. Presentations also include data from a 14-day GLP toxicology study of SPR206 in monkeys, one of the two species in which it was tested.  Data on the spectrum of activity and toxicity support Spero's belief that SPR206 has the potential for wide therapeutic margins in the treatment of Gram-negative infections in the hospital setting. Spero plans to initiate a Phase 1 clinical trial of SPR206 in 2019. 

"We are excited to share PK/PD data for SPR994, our oral carbapenem product candidate, that we believe further support the initiation of our planned pivotal Phase 3 trial of SPR994 for the treatment of cUTI around year-end 2018," said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. "We also look forward to presenting new data on SPR206 that were instrumental in our decision to advance the molecule into a Phase 1 clinical trial in 2019 as we continue to execute on our mission to bring new therapies to patients to treat current and emerging drug-resistant infections."

Presentations pertaining to SPR994, Spero's broad-spectrum oral carbapenem antibiotic product candidate currently in a Phase 1 SAD/MAD clinical trial, are below. SPR859 is the microbiologically active metabolite of SPR994, which is formulated as a prodrug, specifically tebipenem pivoxil.

  • Pharmacokinetics and Pharmacodynamics of Tebipenem (SPR859) for Multidrug Resistant Enterobacteriaceae in a Hollow Fibre Infection Model – Poster L2; Category 3: Drug Development
     
  • Pharmacokinetics and Pharmacodynamics of SPR994 for Multidrug Resistant Enterobacteriaceae – Poster L3; Category 3: Drug Development
     
  • Current oral (PO) regimen options are suboptimal for hospitalized patients with urinary tract infections (UTI) due to contemporary resistant Enterobacteriaceae (ENT): A multicenter analysis – Poster 140; Category 4: Epidemiology
     
  • The impact of antibiotic resistance on hospitalized patients with Enterobacteriaceae (ENT) urinary tract infections (UTI): A multicenter analysis – Poster 141; Category 4: Epidemiology

Presentations pertaining to SPR206, Spero's investigational product candidate from its Potentiator Platform that is expected to enter a Phase 1 clinical trial as a single agent in 2019 and is under development to treat MDR Gram-negative infections in the hospital setting, are below.

  • Antibiotic Potentiators – Oral presentation; Wednesday, 5 September
     
  • In Vitro Activity Evaluation of a Next-Generation Polymyxin, SPR206, against Non-Fermentative Gram-Negative Bacilli Responsible for Human Infections – Poster 80; Category 3: Drug Development
     
  • Activity of Investigational Polymyxin-B-like Compound (SPR206) Against Set of Enterobacteriaceae Organisms Responsible for Human Infections – Poster 81; Category 3: Drug Development
     
  • In Vivo Efficacy of SPR206 in an Immunocompetent Murine Ascending UTI Infection Model Caused by Escherichia coli – Poster 138; Category 3: Drug Development
     
  • In Vivo Efficacy of SPR206 in Murine Lung and Thigh Infection Models Caused by Multi-Drug Resistant Pathogens Pseudomonas aeruginosa and Acinetobacter baumannii – Poster 139; Category 3: Drug Development
     
  • Understanding the SAR Interplay for Kidney Exposure and Cytotoxicity Facilitates the Design of Improved Polymyxin Derivatives – Identification of SPR206 as a Development Candidate – Poster 145; Category 3: Drug Development
     
  • A GLP 14-Day Repeat Dose Toxicology Study of SPR206 in Monkeys – Poster 146; Category 3: Drug Development

Posters will be available for viewing throughout the conference and after the start of the conference abstracts can be accessed through the ESCMID 2018 website.

About SPR994

SPR994 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 common pediatric infections. Carbapenems are an important class of antibiotics because they have been demonstrated to be safe and effective against drug-resistant Gram-negative bacterial infections. The Company initiated a Phase 1 clinical trial of SPR994, designed as a double-blind, placebo-controlled, ascending dose, multi-cohort study, in healthy subjects, in October 2017.  The trial is assessing the safety, tolerability, and pharmacokinetics of SPR994 to enable dose selection for Spero's planned pivotal Phase 3 clinical trial.  Spero announced interim data from the trial in July 2018 and expects to report final data from the MAD portion of the trial in the third quarter of 2018.   Pending discussions from a pre-Phase 3 meeting with the FDA in the second half of 2018, Spero plans to initiate a pivotal Phase 3 clinical trial of SPR994 for the treatment of cUTI around year-end 2018 in support of a new drug application (NDA).  In preclinical studies, SPR994 has shown potent antibiotic activity against Gram-negative bacteria, including E. coli-producing extended-spectrum beta-lactamases (ESBLs) and ESBL-producing Klebsiella pneumoniae, similar to IV-administered ertapenem. Approximately 1,200 subjects have been dosed with tebipenem in clinical and pharmacologic studies conducted by Meiji during its development of tebipenem in Japan.  In addition, available post-marketing outcomes data report the safety and efficacy of tebipenem in 3,540 pediatric patients with pneumonia, otitis media or sinusitis, and these data are consistent with the safety profile of tebipenem as observed in the clinical trial conducted by Meiji.

About the Spero Potentiator Platform

The Potentiator Platform molecules are designed to treat Gram-negative bacterial infections through the molecules' interactions with the bacteria's outer cell membrane as a monotherapy or by co-administering our Potentiator Platform molecules with existing antibiotics, potentially making the existing antibiotics more effective by clearing a path for them to enter and kill the bacteria. Spero has two Potentiator Platform product candidates – SPR741, a combination IV-administered agent that has been evaluated in vitro in which we observed expansion of the spectrum and increase in potency of a co-administered antibiotic; and SPR206, a direct acting IV-administered agent that has shown in vitro activity alone. Both have demonstrated potency in vitro against Gram-negative bacteria, including organisms identified by the Centers for Disease Control and Prevention, or the CDC, and the World Health Organization, or the WHO, as urgent and serious threats to human health. In preclinical studies, SPR741 was able to potentiate over two dozen existing antibiotics by expanding their activity against Gram-negative pathogens and has been evaluated in two Phase 1 clinical trials in healthy volunteers supporting its tolerability. SPR206 is designed to also have antibiotic activity as a single agent against MDR and extremely drug resistant, or XDR, bacterial strains, including variants isolated in Pseudomonas aeruginosa, Acinetobacter baumannii and carbapenem-resistant Enterobacteriaceae. Based on positive results from the preclinical toxicology studies for SPR206, Spero plans to initiate a Phase 1 clinical trial for SPR206 in 2019. The Company expects that data from a Phase 1 clinical trial of SPR206, together with the data from our completed Phase 1b clinical trial of SPR741, will enable the selection of a lead candidate from the Potentiator Platform to move forward into late stage development. 

SPR206 Research Support

This project has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500014C.

About Spero

Spero is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections.

Spero'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.

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 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 infection.

For more information, visit https://sperotherapeutics.com.

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 Spero's preclinical studies and clinical trials and its 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, 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 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; 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 we periodically make 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 Contact: 
Sharon Klahre
Director, Investor Relations
857-242-1547
IR@sperotherapeutics.com

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