Spero Therapeutics Announces FDA Acceptance of IND Application for SPR994
February 04 2019 - 7:00AM
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, today
announced the acceptance by the U.S. Food and Drug Administration
(FDA) of its Investigational New Drug (IND) application for SPR994,
Spero’s lead product candidate designed to be the first oral
carbapenem antibiotic, for the treatment of complicated urinary
tract infections (cUTI). This IND acceptance will enable
Spero to initiate U.S. enrollment in its planned global, single
pivotal Phase 3 clinical trial of SPR994 in cUTI.
“With the FDA’s acceptance of our IND
application for SPR994, we are excited to continue our Phase 3
initiation efforts, including opening clinical trial sites for
enrollment in the U.S.," said Ankit Mahadevia, M.D., Chief
Executive Officer of Spero Therapeutics. "We look forward to
enrolling patients in our single pivotal Phase 3 clinical trial
with the hope, following approval, of providing patients with the
option for an oral carbapenem to address the serious unmet need of
multi-drug resistant infections.”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. The trial
will incorporate a lead-in cohort of 70 patients with
intensive pharmacokinetics assessment to confirm the dose and
exposure in the cUTI patient population. Spero anticipates
receiving interim pharmacokinetic data from the trial’s lead-in
cohort in the second half of 2019. In addition, Spero will
conduct routine ancillary clinical pharmacology studies in parallel
with the ADAPT-PO clinical trial, including a renal insufficiency
study, a thorough QT prolongation study and a drug-drug interaction
study. Spero has begun start-up activities for the ADAPT-PO
clinical trial and anticipates opening trial sites to support study
enrollment in the first quarter 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 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 in the first quarter of 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
TherapeuticsSpero Therapeutics, Inc. 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 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,
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 (NTM) infections.For more
information,
visit https://sperotherapeutics.com.Forward-Looking
StatementsThis 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 interim data from the
Phase 3 trial’s lead-in cohort; 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, including
SPR994, 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, clinical outcomes and findings of ancillary
supportive studies to be conducted in parallel with the planned
Phase 3 trial; 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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