Spero Therapeutics Announces Positive Recommendation to Continue Phase 3 Clinical Trial of SPR994 as Planned Following Indepe...
October 03 2019 - 8:00AM
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 and rare
diseases, today announced that an independent review committee
evaluated pharmacokinetic data following enrollment of the first 70
patients in Spero’s ongoing ADAPT-PO pivotal Phase 3 clinical trial
of SPR994, Spero’s oral carbapenem product candidate, and
recommended that Spero continue the trial using the
protocol-defined dose without modification.
“The Phase 3 trial is designed to evaluate
whether an oral-only regimen of SPR994 can achieve an outcome
similar to that observed with an intravenous antibiotic therapy in
patients with complicated urinary tract infections. If
SPR994 achieves this outcome and is ultimately approved, we believe
it would represent a critical clinical and economic value
proposition for the more than two million patients resistant to
oral therapies currently used to treat such infections,”
said Ankit Mahadevia, M.D., Chief Executive Officer
of Spero Therapeutics. “A primary objective of the
independent review committee was to confirm that plasma levels of
SPR994 in patients in the Phase 3 trial support the selected
treatment dose consistent with our goals for the trial. We are very
pleased that the independent review committee, after reviewing data
from 33 patients who had been randomized to SPR994 in the Phase 3
trial, determined that the plasma levels of SPR994 in those
patients were suitable and recommended that we continue the trial
without dose modification. This decision, based on patient
data in context of our clinical trial, gives us additional
confidence in SPR994’s potential to meet the needs of patients with
resistant infections. Enrollment continues to be on track,
and we expect to report top-line data from the Phase 3 trial in the
third quarter of 2020.”
The independent review committee reviewed
interim plasma concentration data from 33 patients who were
randomized to SPR994 in the ongoing ADAPT-PO pivotal Phase 3
clinical trial for the treatment of complicated urinary tract
infections (cUTI) and acute pyelonephritis (AP). ADAPT-PO is
designed as a double-blind, double-dummy clinical trial to compare
oral SPR994 dosed as 600 mg TID with a standard-of-care intravenous
(IV) antibiotic, ertapenem, in approximately 1,200 patients with
cUTI or AP, randomized 1:1 in each arm. The Phase 3 trial
will continue as planned and Spero expects to report top-line data
in the third quarter of 2020.
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 observed to be safe and
effective against drug-resistant Gram-negative bacterial
infections. Spero is conducting a 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)).
SPR994 has been granted Qualified Infectious Disease Product (QIDP)
and Fast Track designations by the FDA for the treatment of
cUTI.
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.
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.
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; 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
Senior Director, Investor Relations 857-242-1547
IR@sperotherapeutics.com
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