SPR741 Phase 1b Drug-Drug Interaction Study and SPR206 IND-enabling Studies Provide Support for Further
Clinical Development
- Phase 1b data demonstrates pharmacokinetic compatibility and tolerability of SPR741 when co-administered
with b-lactam antibiotics and continues to build on safety profile observed in prior clinical study
- SPR206 IND-enabling studies demonstrate potential for wide therapeutic margins and broad antimicrobial
spectrum as a single agent, supporting progression to clinical studies
- Both compounds represent novel, differentiated potential approaches to treating MDR Gram-negative infections,
for which no new classes of therapies have been approved for 30 years
CAMBRIDGE, Mass., May 23, 2018 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset
clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug
resistant (MDR) bacterial infections, today announced results from the Company’s Phase 1b drug-drug interaction trial of SPR741,
the first product candidate from its Potentiator Platform, demonstrating pharmacokinetic (PK) compatibility and tolerability when
co-administered with b-lactam antibiotics. Spero also announced results today from the IND-enabling studies of SPR206, its second
product candidate from the platform, that demonstrate the potential for this agent to achieve wide therapeutic margins in the
treatment of serious Gram-negative infections and are supportive of advancement into clinical development.
“Phase 1b data highlighting tolerability and PK compatibility for SPR741 when dosed in combination with select
b-lactams and pre-clinical data demonstrating potential for wide therapeutic margins for SPR206 as a single agent are encouraging
and continue to support the potential of our Potentiator Platform to provide innovative drug candidates for multidrug-resistant
Gram-negative infections in the hospital,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics.
SPR741:
In the Phase 1b trial, SPR741 was administered as a single dose of 400 mg alone and in combination with three
commonly used b-lactam antibiotics, piperacillin/tazobactam, ceftazidime, and aztreonam. The trial enrolled 27 healthy
volunteers in a cross over study design. The goal of the Phase 1b trial was to assess the impact, if any, on the PK or tolerability
of SPR741 and the PK or tolerability of the b-lactam drug when the two are dosed together. The single dose data indicate that the
administration of b-lactam antibiotics had no impact on PK or tolerability of SPR741, supporting further development of SPR741 as a
combination agent for the treatment of MDR infections.
Results from the Phase 1b study build on the data from the Phase 1 SAD/MAD study announced in October, 2017 and
presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) Conference in April 2018 that
showed SPR741 to be generally well tolerated at doses up to and including 600 mg every 8 hours for 14 days. These data also
complement results presented at ECCMID 2018 showing that combinations of SPR741 and b-lactams were active in vitro and in
preclinical infection models.
SPR206:
SPR206 was assessed in a suite of non-clinical, IND-enabling studies, including 14-day, two species, GLP
toxicology experiments, and in vitro and in vivo GLP safety pharmacology, and absorption, distribution,
metabolism, and excretion (ADME) studies. The data provide support for an acceptable safety profile and combined with earlier
microbiological and in vivo efficacy testing of SPR206, support its advancement as clinical candidate designed to treat
MDR and extensively drug-resistant (XDR) bacterial strains, including carbapenem-resistant Pseudomonas aeruginosa,
Acinetobacter baumannii, and Enterobacteriaceae. The composite data suggest SPR206 has the potential for wide therapeutic
margins in the setting of serious hospital Gram-negative infections.
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. We have two Potentiator Platform product candidates – SPR741, our 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, our 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 now been evaluated in two Phase 1 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.
The work on these compounds was partially supported by non-dilutive funding from 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. This work is also partially supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and
an award from the Wellcome Trust, as administrated by CARB-X. The contents of the press release 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 the Wellcome Trust.
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, an orphan infectious disease.
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 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” section
of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 2, 2018 and
the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2018, and risks described
in other filings the Company may make with the Securities and Exchange Commission in the future. 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
![Primary Logo](https://resource.globenewswire.com/Resource/Download/f9b7b81c-0c18-4d60-ae5e-ef950e9ff20b?size=1)
![](http://www.globenewswire.com/newsroom/ti?ndecode=NzA2MzkjNzI5MTk0Nw==)