- Inter-agency collaboration among BARDA, DTRA, USAMRIID and Spero to fund further clinical development of product
candidate SPR994
- Planned pivotal Phase 3 trial of SPR994 on track to initiate around year-end 2018
CAMBRIDGE, Mass., July 16, 2018 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq:SPRO) (Spero), a
multi-asset clinical-stage biopharmaceutical company focused on developing and commercializing novel antibiotics to treat
multi-drug resistant bacterial infections, today announced that it was awarded funding of $15.7 million, with the potential for up
to an additional $28.5 million over 5 years, from the Biomedical Advanced Research and Development Authority (BARDA). The funding
will support the further clinical development of Spero’s oral carbapenem product candidate, SPR994, for the treatment of
complicated urinary tract infections (cUTIs) caused by antibiotic resistant Gram-negative bacteria. As part of the inter-agency
collaboration with Spero, a series of studies to assess the efficacy of SPR994 in the treatment of infections caused by biodefense
threats such as anthrax, plague and melioidosis will be conducted by the U.S. Army Medical Research Institute of Infectious
Diseases (USAMRIID). In addition, the Defense Threat Reduction Agency (DTRA) will provide support up to $10 million to fund the
nonclinical biodefense aspects of the inter-agency collaboration. The collaboration may also include a clinical trial in
pneumonia patients, an indication for which tebipenem, SPR994’s active pharmaceutical ingredient, is currently approved in Japan
for pediatric use. Together, the two agencies will provide up to $54.2 million in total funding for the clinical development
and biodefense assessment of SPR994, a portion of which is subject to the exercise of options by BARDA and Spero’s achievement of
specified milestones.
“We are honored to be the recipient of an award and to join BARDA and DTRA in this unique inter-agency
collaboration. We look forward to advancing SPR994 through clinical development for public and biodefense use as we target public
health needs caused by emerging drug-resistant infections,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “We believe the
funding is a validation of the clinical potential of SPR994 across a broad treatment landscape, and of the ability of a small
biotech company to work towards bringing these innovative therapies to patients in collaboration with our partners at BARDA and
DTRA.”
The award from BARDA commits $15.7 million of guaranteed initial funding and up to an additional $28.5 million
over 5 years if BARDA exercises all of its options under the award. Additionally, DTRA will commit $1.25 million of
initial support, and up to an additional $8.75 million upon the achievement of specified milestones.
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. Spero 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 Phase 1 data from the trial in early July and expects to report final data from the MAD portion of the Phase 1 clinical
trial in the third quarter of 2018. Pending discussions from a pre-Phase 3 meeting with the FDA, which Spero plans
to request 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 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.
About BARDA
The Biomedical Advanced Research and Development Authority (BARDA), an agency within the HHS Office of the
Assistant Secretary for Preparedness and Response (ASPR), provides a comprehensive, integrated, portfolio approach to the advanced
research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic
tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological,
radiological, and nuclear threats, pandemic influenza and emerging infectious diseases. For more information, visit
https://www.phe.gov/about/barda/.
About DTRA
The Defense Threat Reduction Agency (DTRA), an agency within the United States Department of Defense (DoD), is
the official Combat Support Agency for countering weapons of mass destruction (chemical, biological, radiological, nuclear, and
high explosives). DTRA’s mission is to enable the DoD and the U.S. Government to prepare for and combat weapons of mass
destruction, and has the responsibility to manage and integrate the DoD chemical and biological defense science and technology
programs. DTRA's continued effort to enhance the combat support mission also advances public health services by developing
innovative technologies that protect against biological threats. For more information, visit http://www.dtra.mil/.
About USAMRIID
The United States Army Medical Research Institute of Infectious Disease’s mission is to provide leading edge
medical capabilities to deter and defend against current and emerging biological threat agents. Research conducted at USAMRIID
leads to medical solutions—vaccines, drugs, diagnostics, and information—that benefit both military personnel and civilians.
USAMRIID plays a key role as the lead military medical research laboratory for the Defense Threat Reduction Agency’s Joint Science
and Technology Office for Chemical and Biological Defense. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research
and Materiel Command. For more information, visit http://www.usamriid.army.mil/.
[The information contained in this press release does not necessarily reflect the position or the policy of
the U.S. Government and no official endorsement should be inferred.]
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 United States 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; whether BARDA elects to exercise its options to provide Spero with additional funding and
whether Spero achieves the milestones that are a precondition to its receipt of additional DTRA funding; 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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