Spero Announces Appointment of Cynthia Smith to its Board of Directors
March 19 2019 - 8:00AM
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 the appointment of Cynthia Smith to its
Board of Directors, effective as of today. Ms. Smith has more than
20 years of corporate leadership experience within the healthcare
sector, most recently serving as Chief Commercial Officer and a
member of the executive team of ZS Pharma where she helped lead the
company from development to commercialization through its
acquisition by AstraZeneca.
“We are pleased to welcome Cynthia to our Board
of Directors,” said Ankit Mahadevia, M.D., Chief Executive
Officer of Spero Therapeutics. “Cynthia’s broad corporate
leadership and commercialization experience will be an invaluable
asset to Spero as SPR994 progresses through its planned Phase 3
trial toward commercialization. In our continued effort to
bring SPR994 to patients, we are looking forward to leveraging
Cynthia’s experience building commercial infrastructure as well as
benefiting from her market access and policy experience.”
Prior to joining ZS Pharma, Ms. Smith served as
Vice President, Market Access and Commercial Development at Affymax
from 2008 to 2013. She also held various senior leadership
positions in market access, corporate strategy, government
relations and external affairs at Merck from 2000 to 2008.
Before transitioning to the biopharmaceutical industry, Ms.
Smith served as a healthcare policy analyst in the White House
Office of Management and Budget from 1995 to 2000.
“This is an exciting time for Spero with its
lead drug, SPR994, entering a Phase 3 trial and two additional
promising drug candidates, SPR720 and SPR206, currently in clinical
trials,” Ms. Smith said. “I’m looking forward to working with the
Board and the management team to lay the groundwork ahead of a
possible commercial launch for SPR994 and contributing to the
development strategy of the pipeline.”
Ms. Smith currently serves on the boards of
Dicerna Pharmaceuticals and Akebia Therapeutics, and previously
served on the board of Nivalis Therapeutics from 2016 to
2017. She earned her M.B.A. from the Wharton School of the
University of Pennsylvania, and a M.S. in public policy from the
Eagleton Institute of Politics at Rutgers University. Ms. Smith
received a B.A. from the University of North Carolina at Chapel
Hill.
About Spero
Spero 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 has
begun start-up activities for the ADAPT-PO Phase 3 clinical trial
of SPR994 for the treatment of complicated urinary tract infections
and anticipates opening trial sites to support study enrollment
around the end of March 2019.
Spero is also advancing SPR720, its novel oral
therapy product candidate designed for the treatment of
non-tuberculous mycobacterial (NTM) infections.
In January 2019, Spero initiated a Phase 1 clinical trial of
SPR720 in healthy subjects and expects top-line data from this
trial in the second half of 2019.
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,
SPR741 and SPR206, designed to treat MDR Gram-negative infections
in the hospital setting. In December 2018, Spero initiated a
Phase 1 clinical trial of SPR206 in healthy subjects and expects
top-line data from this trial in the second half of 2019.
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 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 planned
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,
including the anticipated timing of the opening of sites to support
enrollment into the planned pivotal Phase 3 clinical trial of
SPR994; 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 planned Phase 3 clinical trial of
SPR994 and top-line data from the Phase 1 clinical trial of SPR206
and the Phase 1 clinical trial of SPR720; 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 Director, Investor Relations
857-242-1547 IR@sperotherapeutics.com
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