Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset
clinical-stage biopharmaceutical company, focused on identifying,
developing and commercializing treatments in areas of high unmet
need involving rare diseases and multi-drug resistant (MDR)
bacterial infections, announced today that it received written
agreement from the U.S. Food and Drug Administration (FDA), under a
Special Protocol Assessment (SPA), on the design and size of
PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in
patients with complicated urinary tract infection (cUTI), including
acute pyelonephritis (AP).
“PIVOT-PO was designed in collaboration with GSK
to provide tebipenem HBr with a clinical path to becoming the first
oral carbapenem antibiotic for treatment of cUTI, if approved,”
said Dr. Kamal Hamed, Chief Medical Officer of Spero. “With
increasing prevalence of antibiotic-resistant bacteria, cUTI
patients often have no choice but to receive an intravenous (IV)
carbapenem antibiotic in a hospital setting. The goal of our
tebipenem HBr program is to provide appropriate patients with an
efficacious oral option for the treatment of cUTI. We believe that
tebipenem HBr has the potential to deliver strong value to the
healthcare system.”
PIVOT-PO is a global, randomized, double-blind,
pivotal Phase 3 clinical trial of oral tebipenem HBr vs. IV
imipenem cilastatin, in hospitalized adult patients with cUTI/AP.
The primary efficacy endpoint will be overall response (composite
of clinical cure plus microbiological eradication) at the
test-of-cure visit. The primary analysis for the trial will be an
assessment of non-inferiority (NI) in the microbiological
intention-to-treat population, based on a 10% NI margin, which is
consistent with FDA guidance for non-inferiority studies in
cUTI/AP. The FDA has indicated that positive and persuasive results
from PIVOT-PO, along with previously completed studies, could be
sufficient to support approval of tebipenem HBr as a treatment for
cUTI, including pyelonephritis, for a limited use indication.
Spero is also eligible to receive the following
milestone/royalty payments under the terms of its license agreement
with GSK, conditional upon achievement of certain progression of
milestones: (1) up to an additional $120 million in development
milestones as the Phase 3 clinical trial progresses; (2) up to $150
million in potential commercial milestones based on first
commercial sales; (3) up to $225 million in potential sales-based
milestones; and (4) low-single digit to low- double digit (if sales
exceed $1 billion) tiered royalties on net product sales of
tebipenem HBr in all territories, except Japan and certain other
Asian countries.
About
Tebipenem HBr
Tebipenem HBr (tebipenem pivoxil hydrobromide;
formerly SPR994) is Spero’s novel late-stage development asset, an
oral formulation tablet of tebipenem pivoxil, a carbapenem
antibiotic of the β-lactam class. Tebipenem pivoxil is marketed by
Meiji Seika Pharma Co. Ltd. (Meiji) in Japan as an oral granule
formulation, Orapenem®, since 2009 for pediatric infections limited
to pneumonia,
otitis media and sinusitis. Carbapenems are an
important subclass of antibiotics in the treatment of
drug-resistant Gram-negative bacterial infections. Tebipenem HBr is
being developed for the treatment of complicated urinary tract
infections, including AP, caused by certain microorganisms. If
approved, tebipenem HBr would be the first oral carbapenem
antimicrobial to receive marketing approval in the United States.
Tebipenem HBr has been granted Qualified Infectious Disease Product
(QIDP) and Fast Track designations by the FDA for the treatment of
cUTI and AP.
Tebipenem HBr
Research Support
Select tebipenem HBr studies have been funded in
part with federal funds from the Department of Health and Human
Services; Administration for Strategic Preparedness and Response;
Biomedical Advanced Research and Development Authority, under
contract number HHSO100201800015C.
About Spero
TherapeuticsSpero Therapeutics, headquartered in
Cambridge, Massachusetts, is a multi-asset, clinical-stage
biopharmaceutical company focused on identifying, developing, and
commercializing novel treatments for bacterial infections,
including multi-drug resistant bacterial infections and rare
diseases.
- Spero Therapeutics is developing
SPR720 as a novel oral therapy candidate for the treatment of a
rare, orphan pulmonary disease caused by non-tuberculous
mycobacterial infections.
- Tebipenem HBr is an investigational
drug in the United States being developed for the treatment of
cUTI, including pyelonephritis, caused by certain bacteria, in
adult patients who have limited treatment options; tebipenem HBr is
not FDA-approved.
- Spero Therapeutics also has an
IV-administered next generation polymyxin product candidate,
SPR206, developed from its potentiator platform, which is in
development to treat MDR Gram-negative infections in the hospital
setting.
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 the design,
initiation, timing, progress and results of Spero's preclinical
studies and clinical trials and its research and development
programs, as well as the regulatory path forward for tebipenem HBr
and potential FDA approval, the potential commercialization of
tebipenem HBr and its future value, the potential receipt of
milestone payments, and royalties on future sales under the license
agreement. 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 tebipenem HBr, SPR720
and SPR206 will advance through the 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 FDA or
equivalent foreign regulatory agencies; whether the FDA will
ultimately approve tebipenem HBr and, if so, the timing of any such
approval; whether the FDA will require any additional clinical data
or place labeling restrictions on the use of tebipenem HBr that
would delay approval and/or reduce the commercial prospects of
tebipenem HBr; whether a successful commercial launch can be
achieved and market acceptance of tebipenem HBr can be established;
whether results obtained in preclinical studies and clinical trials
will be indicative of results obtained in future clinical trials;
Spero's reliance on third parties to manufacture, develop, and
commercialize its product candidates, if approved; Spero’s need for
additional funding; the ability to commercialize Spero's product
candidates, if approved; Spero's ability to retain key personnel;
Spero’s ongoing leadership transitions; 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 and 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.
Investor
Relations Contact:Ted JenkinsVice
President, Investor Relations and Strategic Finance
IR@sperotherapeutics.com(617) 798-4039
Media
Inquiries:Lora Grassilli, Health Media Relations
Zeno Group lora.grassilli@zenogroup.com646-932-3735
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