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 that it has received a $5.9 million award
from the U.S. Department of Defense (DoD) Congressionally Directed
Medical Research Programs (CDMRP) Joint Warfighter Medical Research
Program (Award number W81XWH-19-1-0295). The U.S. Army
Medical Research Acquisition Activity, 839 Chandler Street, Fort
Detrick MD 21702- 5014 is the awarding and administering
acquisition office.
The funding will support the further clinical
development of SPR206, Spero’s intravenous (IV)-administered
product candidate from its Potentiator Platform that is being
developed as an innovative alternative option to treat MDR
Gram-negative bacterial infections. The award commits non-dilutive
funding of $5.9 million over a four-year period to cover the costs
of select Phase 1 pharmacology studies, a 28-day GLP non-human
primate toxicology study, and microbiological surveillance studies
that would be required for a potential New Drug Application (NDA)
submission with the U.S. Food and Drug Administration for
SPR206.
In preclinical studies, SPR206 has demonstrated
activity as a single agent against MDR and extensively drug
resistant (XDR) bacterial strains, including isolates
of Pseudomonas aeruginosa, Acinetobacter
baumannii and carbapenem-resistant Enterobacteriaceae, in
both in vitro and in vivo models of
infection. SPR206 is currently being evaluated in a
first-in-human Phase 1 clinical trial, designed as a double-blind,
placebo-controlled, single and multiple ascending dose,
multi-cohort study in healthy subjects. Spero expects to report
top-line data from this trial in the second half of 2019.
“Spero is dedicated to fighting emerging
drug-resistant infections and tackling this critical problem that
faces our civilian and military populations alike,” said Ankit
Mahadevia, M.D., Chief Executive Officer of Spero. “We are
honored to be selected for this award, which will enable us to
advance the clinical development of SPR206 using non-dilutive
funding, and we look forward to strengthening our existing
relationship with the Department of Defense.”
The DoD recognizes the need for safe, novel
antibiotics effective against MDR organisms that can cause hospital
or community-associated infections in veterans or combat wound
infections in active duty military personnel.
About the Spero Potentiator Platform –
SPR206 and SPR741
Spero’s Potentiator Platform molecules are
designed to treat Gram-negative bacterial infections through the
molecule’s interactions with the bacterium’s outer membrane. The
Potentiator Platform molecules exhibit this effect as a monotherapy
or by co-administration with existing antibiotics. Spero currently
has two Potentiator Platform drug candidates – SPR206, a direct
acting IV-administered agent that has demonstrated broad
Gram-negative antibacterial activity; and SPR741, an
IV-administered agent that has demonstrated Gram-negative
antibacterial activity when co-administered with existing
antibiotics. Both have demonstrated activity against
Gram-negative bacteria, including organisms identified by
the Centers for Disease Control and Prevention and
the World Health Organization as urgent and serious threats to
human health. SPR206 is designed to have antibiotic activity as a
single agent against MDR and XDR bacterial strains, including
carbapenem-resistant Pseudomonas aeruginosa, Acinetobacter
baumannii and Enterobacteriaceae. Spero initiated a Phase
1 trial of SPR206 in December 2018 and anticipates
top-line data from the trial in the second half of 2019. In
preclinical studies, SPR741 was able to potentiate over two-dozen
existing antibiotics by expanding their activity against
Gram-negative pathogens. SPR741 has been evaluated in two
Phase 1 clinical trials in healthy volunteers supporting its safety
and tolerability. Spero believes that its current
intellectual property portfolio and pending patent applications
will provide global protection, including China, the
United States and Europe for SPR206 and SPR741
through 2039 and 2038, respectively.
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 is also advancing SPR720, its novel oral
therapy product candidate designed for the treatment of rare,
orphan disease caused by pulmonary non-tuberculous mycobacterial
(NTM) 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 IV-administered agents,
SPR206 and SPR741, designed to treat MDR Gram-negative infections
in the hospital setting.
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 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; 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 Phase 3 clinical trial of SPR994 and top-line
data from the Phase 1 clinical trial of SPR720 and the Phase 1
clinical trial of SPR206; 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
Senior Director, Investor Relations 857-242-1547
IR@sperotherapeutics.com
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