Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset
clinical-stage biopharmaceutical company focused on identifying,
developing and commercializing novel treatments for
multidrug-resistant bacterial infections, announced today that
SPR720, an orally administered antimicrobial agent being developed
for the treatment of non-tuberculous mycobacterial (NTM)
infections, 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 (TB).
“We are pleased that the FDA has
acknowledged the promise of SPR720 for the treatment of NTM and TB,
by granting QIDP status for the compound,” said Ankit
Mahadevia, M.D., CEO of Spero Therapeutics. “SPR720 has the
potential to become the first approved oral treatment for NTM
infections, an area of high unmet need that requires prolonged
therapy and where no specifically approved orally administered
treatments exist.”
The QIDP designation was created by the
Generating Antibiotic Incentives Now (GAIN) Act and creates
incentives for the development of certain antibiotics that treat
serious or life-threatening infections. The primary incentives are
an additional five-year extension of Hatch-Waxman Act exclusivity,
as well as priority FDA review of the first marketing application
or efficacy supplement for SPR720 and the indication for which QIDP
designation was granted, and the opportunity to request Fast Track
designation for SPR720.
SPR720 is currently being evaluated in a Phase 1
double-blind, placebo-controlled clinical trial designed to assess
the safety, tolerability and pharmacokinetics of SPR720 in healthy
volunteers. The advancement of SPR720 into this first-in-human
clinical trial was based on cumulative data from pre-clinical
safety, toxicology and ADME (absorption, distribution,
metabolism and excretion) studies as well as nonclinical efficacy
studies demonstrating potent activity for SPR270 in
vitro and in vivo against TB and clinically
important NTM species, including Mycobacterium
avium complex and Mycobacterium abscessus. The
collective pre-clinical data to date suggest that SPR720 has an
acceptable safety profile, with encouraging activity against the
target NTM and TB pathogens, drug distribution to key sites of
infection, such as the lung, and a wide therapeutic margin.
Spero expects to receive top-line data from the Phase 1 clinical
trial in the second half of 2019.
SPR720 Research Support
Research reported in this publication was
partially supported by the National Institute of
Allergy and Infectious Diseases, part of the National
Institutes of Health, under Award Number R44AI131749. The
content is solely the responsibility of the authors and does not
necessarily represent the official views of the National
Institutes of Health.
About SPR720
SPR720 represents a novel class of antibacterial
agents that target enzymes essential for bacterial DNA replication.
SPR720 was in-licensed from Vertex and is under development as an
oral therapy for the treatment of
non-tuberculous mycobacterial (NTM) infections. 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 regimen 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. SPR720 is currently in a Phase 1
clinical trial in healthy subjects and Spero expects to receive
top-line data from the trial in the second half of 2019.
Pre-clinical in vitro and in vivo studies have
demonstrated the potency of SPR720 against a range of bacteria that
cause TB and pulmonary NTM infections, including Mycobacterium
avium complex and Mycobacterium abscessus, a highly
resistant species responsible for high mortality. Spero believes
that its intellectual property portfolio for SPR720 will provide
protection globally, including in the United
States and Europe, through 2033.
About Spero
Therapeutics
Spero Therapeutics, Inc. is a multi-asset,
clinical-stage biopharmaceutical company focused on identifying,
developing and commercializing novel treatments for MDR bacterial
infections.
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 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.
Spero is also advancing SPR720, its novel oral
therapy product candidate designed for the treatment of
non-tuberculous mycobacterial (NTM) infections.
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
Spero’s preclinical studies and clinical trials and its research
and development programs, including statements regarding
management’s assessment of the results of the SPR720 preclinical
studies and management’s belief that SPR720 may demonstrate
favorable clinical results and may be able to address an unmet
medical need, the therapeutic potential of SPR720, the timing of
clinical data, including the availability of interim data from the
Phase 1 clinical trial of SPR720, 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 the SPR720 preclinical studies will be
indicative of results obtained in future clinical trials; whether
SPR720 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; Spero’s ability to continue obtaining and maintaining
intellectual property protection for its product candidates; 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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