Spero Therapeutics Announces Initiation of SPR720 Phase 1 Clinical Trial
January 29 2019 - 8:00AM
Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset
clinical-stage biopharmaceutical company focused on identifying,
developing and commercializing novel treatments for
multidrug-resistant (MDR) bacterial infections, announced today
that it has initiated a Phase 1 clinical trial of SPR720, an orally
administered antimicrobial agent being developed for the treatment
of non-tuberculous mycobacterial (NTM) infections.
“SPR720 is a promising drug candidate that has
the potential to become the first approved oral treatment for NTM
infections. NTM infections cause chronic, debilitating disease and
represent an area of high unmet need as there are no specifically
approved orally administered treatment options,” said Ankit
Mahadevia, M.D., CEO of Spero Therapeutics. “We look forward
to receiving top-line results from the Phase 1 trial assessing the
safety, tolerability and pharmacokinetics of SPR720 in the second
half of 2019.”
The Phase 1 clinical trial evaluating SPR720 is
a double-blind, placebo-controlled, ascending dose, multi-cohort
study in healthy subjects consisting of single ascending dose and
multiple ascending dose cohorts. The advancement of SPR720 into the
Phase 1 clinical assessment was based on SPR720’s favorable profile
exhibited in a suite of pre-clinical in vitro and in
vivo safety, toxicology and ADME (absorption, distribution,
metabolism and excretion) studies, as well as SPR720’s
demonstration of potent in vitro and in vivo activity versus
multiple, clinically important species of NTM,
including Mycobacterium avium complex
and Mycobacterium abscessus. The collective pre-clinical
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. Spero expects to receive top-line data from the Phase
1 clinical trial in the second half of 2019.
SPR720 Research SupportResearch
reported in this publication was partially supported by
the National Institute of Allergy and Infectious
Diseases 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
SPR720SPR720 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. Pre-clinical in
vitro and in vivo studies have demonstrated the
potency of SPR720 against a range of bacteria that cause 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
TherapeuticsSpero 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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