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 entered into a collaboration with
the Bill & Melinda Gates Medical Research Institute (Gates MRI)
to develop SPR720 for the treatment of lung infections caused by
Mycobacterium tuberculosis (Mtb), an indication that is designated
as a critical concern by the World Health Organization (WHO).
SPR720 is an orally administered antimicrobial
agent currently being developed by Spero Therapeutics for the
treatment of rare non-tuberculous mycobacterial (NTM)
infections. Spero has granted Gates MRI an exclusive license
to develop, manufacture and commercialize SPR720 for the treatment
of tuberculosis (TB) in low- and middle- income countries (LMIC).
Gates MRI will conduct and fund preclinical and clinical
studies for the development of SPR720 against TB, and also fund
certain collaborative activities in furtherance of Gates MRI’s
charitable purposes. SPR720 was discovered by Vertex
Pharmaceuticals and was acquired by Spero Therapeutics in 2016.
Vertex and Spero have reached an agreement to enable the
collaboration between Spero and the Bill & Melinda Gates
Medical Research Institute for the further development of this
compound in low- and middle- income countries.
“We are excited about the prospects of SPR720
for treatment of NTM, and also see an important unmet need in the
treatment of TB around the world. We look forward to working with
Gates MRI to advance the development of SPR720 to help address the
current public health crisis in TB within LMIC,” said Ankit
Mahadevia, M.D., Chief Executive Officer of Spero
Therapeutics. “Spero will benefit from the significant
development and industry experience that the Gates MRI team can
offer as well as synergies between the TB and NTM development paths
as SPR720 progresses through clinical trials.”
“Our translational medicine focus is on
advancing novel product candidates from the lab to human studies
against diseases that disproportionately affect the poor,” remarked
Bill & Melinda Gates Medical Research Institute Chief Executive
Officer Penny Heaton, MD. “We are very pleased to work with
Spero on SPR720, a potential new tool to meaningfully address
tuberculosis, the leading causing of death from infectious disease
in the world.”
SPR720 is currently being evaluated in a
double-blind, placebo-controlled Phase 1 clinical trial to assess
the safety, tolerability and pharmacokinetics of SPR720 in healthy
volunteers. Spero expects to report top-line data from the
Phase 1 clinical trial in the second half of 2019. Preclinical in
vitro and in vivo studies have demonstrated the
potency of SPR720 against clinically important mycobacteria,
including NTM species Mycobacterium avium complex
and Mycobacterium abscessus, as well as Mycobacterium
tuberculosis. The collective data to date suggest that SPR720
has an acceptable safety profile, encouraging target pathogen
efficacy, drug distribution to key sites of infection, such as the
lung, and a wide therapeutic margin.
About SPR720
SPR720 represents a novel class of antibacterial
agents that target enzymes essential for bacterial DNA replication.
SPR720 was acquired from Vertex and is currently under development
as an oral therapy for the treatment of
non-tuberculous mycobacterial (NTM) infections, a rare orphan
disease. NTM are ubiquitous environmental pathogens that can
cause progressive lung damage and respiratory failure, particularly
in patients with compromised immune systems or underlying pulmonary
disorders. Although rare, the incidence of pulmonary NTM infections
is increasing worldwide. Treatment of pulmonary NTM infections
requires prolonged therapy (continuing for approximately 12 to 24
months) with a combination of mostly unapproved drugs and is
frequently complicated by tolerability and/or toxicity issues.
Additionally, there are currently no oral antibiotics specifically
approved for use to treat pulmonary NTM infections. Thus, if
successfully developed, SPR720 has the potential to address an
important unmet need as the first oral antibiotic approved for the
treatment of this debilitating disease. Under Spero’s
collaboration with Gates MRI, SPR720 will also be developed for the
treatment of Mycobacterium tuberculosis (Mtb) infections.
Tuberculosis is a priority pathogen as defined by the World Health
Organization with it being one of the top ten causes of death
worldwide, and a situation where resistance is increasing and
current treatments approaches are not optimal. Spero believes
that its intellectual property portfolio for SPR720 will provide
protection globally, including in the United
States and Europe, through 2033. SPR720 has been granted
Qualified Infectious Disease Product (QIDP) designation by
the U.S. Food and Drug Administration for the treatment
of lung infections caused by non-tuberculous mycobacteria and lung
infections caused by Mycobacterium
tuberculosis (Mtb).
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.
About Gates MRI
The Bill & Melinda Gates Medical Research
Institute (Gates MRI) is a non-profit biotechnology development
organization focused on reducing or eliminating vexing diseases in
global health. The Gates MRI’s mission is to develop products to
prevent and/or treat tuberculosis, malaria, enteric infections and
maternal, neonatal and childhood diseases, all of which are major
causes of mortality and inequality in Low-Middle Income Countries
(LMIC). Gates MRI takes an integrated approach to product
development: multi-disciplinary teams are at the heart of the
organization, populated by functional area members with deep
translational medicine expertise. The institute is different than a
large pharma organization with a focus on diseases that have little
commercial potential but create a huge burden of morbidity and
mortality in LMIC. Unlike biotechs, Gates MRI has secured long-term
funding to accomplish a clear mission. Further, building on the
partner network of the Bill & Melinda Gates Foundation, the
organization is uniquely positioned to rally both private- and
public-sector partners and help bring their vast array of expertise
and resources to bear against Gates MRI’s diseases of interest.
Gates MRI was founded to serve the global health community by
accelerating the availability of efficacious drugs, vaccines, and
biologics with an acceptable safety profile for low income
countries.
For more information, visit:
https://www.gatesmri.org/
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; Spero’s ability to leverage data from
Gates MRI’s studies in TB, the Gates MRI’s development and industry
experience and synergies expected to result from the collaboration
with Gates MRI in the development of SPR720 for the treatment of
NTM infections; 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 the anticipated benefits and potential of Spero’s
collaboration with the Gates MRI can be achieved; 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
Gates MRI Contact:Jane A.
KramerExternal Affairs & Communications
Leader781-799-9524media@gatesmri.org
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