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 the U.S. Food and Drug
Administration (FDA) granted Fast Track Designation for SPR994,
Spero’s lead product candidate designed to be the first oral
carbapenem antibiotic, for the treatment of complicated urinary
tract infections (cUTI) and acute pyelonephritis.
“We are pleased that the FDA has granted
fast track status for SPR994,” said Ankit Mahadevia, M.D., CEO
of Spero Therapeutics. “Receiving Fast Track status highlights
the serious unmet need of multi-drug resistant infections and we
look forward to working closely with the FDA as we conduct our
planned pivotal Phase 3 clinical trial through the possible NDA
submission with the goal of providing patients with the option of
oral SPR994 as soon as possible, if approved.”
The FDA's Fast Track program facilitates
development and expedites review of drugs intended to treat serious
or life-threatening conditions that demonstrate the potential to
address unmet medical needs. Fast Track Designation provides
opportunities for more frequent interaction with the FDA review
team to expedite development and review as well as provides an
opportunity for rolling review of the NDA upon request and
agreement with the FDA. In addition, the Fast Track program allows
for eligibility for Accelerated Approval and Priority Review, if
relevant criteria are met. In addition to Fast Track
Designation, SPR994 was previously granted QIDP designation.
SPR994 will receive FDA priority review of the first
marketing application or efficacy supplement for SPR994 and the
indication for which QIDP designation was granted.
Spero’s planned pivotal Phase 3 clinical trial
of SPR994, ADAPT-PO, is designed as a double-blind, double-dummy
trial to compare oral SPR994 with an existing standard of care
intravenous (IV) antibiotic, ertapenem, in approximately 1,200
patients randomized 1:1 in each arm. The primary endpoint of
the pivotal trial will be the combined clinical and microbiological
response at the test of cure with a
10% non-inferiority margin versus IV ertapenem. Spero has
begun start-up activities for the ADAPT-PO clinical trial and
anticipates opening trial sites around the end of March 2019 to
support study enrollment. The trial will incorporate a
lead-in cohort of 70 patients with an intensive
pharmacokinetics assessment to confirm the dose and exposure in the
cUTI patient population. Spero expects to receive pharmacokinetic
data from the lead-in cohort in the second half of
2019.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 pediatric infections limited to
pneumonia, otitis media and sinusitis. 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 completed a Phase 1 clinical trial of SPR994
in Australia, designed as a double-blind, placebo-controlled,
ascending dose, multi-cohort study to enable dose selection for
Spero’s planned pivotal Phase 3 clinical trial. The FDA has
accepted Spero’s IND for SPR994 in cUTI/AP and Spero intends to
open trial sites to support enrollment into the pivotal Phase 3
clinical trial of SPR994 entitled ADAPT-PO [(A Phase 3, Randomized,
Double-blind, Double-dummy, Multicenter, Prospective Study to
Assess the Efficacy, Safety and Pharmacokinetics
of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994)
Compared to Intravenous Ertapenem in Patients with Complicated
Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)] for
the treatment of cUTI around the end of March 2019 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 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.SPR994 Research
Support: This project has been funded in part
with Federal funds from the Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness
and Response; Biomedical Advanced Research and Development
Authority, under Contract No. HHSO100201800015C.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
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 planned
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,
including the anticipated timing of the opening of sites to support
enrollment into the planned pivotal Phase 3 clinical trial of
SPR994; 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 planned Phase 3 clinical trial of
SPR994 and top-line data from the Phase 1 clinical trial of SPR206
and the Phase 1 clinical trial of SPR720; 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 Director, Investor Relations
857-242-1547 IR@sperotherapeutics.com
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