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 rare diseases and multi-drug resistant (MDR) bacterial
infections, announced today the first patient, first visit for
PIVOT-PO, a global pivotal Phase 3 clinical trial of tebipenem HBr
in patients with complicated urinary tract infections (cUTI),
including acute pyelonephritis (AP). Spero is entitled to receive
$95 million in development milestone payments from GSK, which is
payable in four equal installments over two years.
“First patient visit, in the PIVOT-PO Phase 3
clinical trial, is an important milestone in our tebipenem HBr
program,” said Sath Shukla, President and CEO of Spero
Therapeutics. "We are developing Tebipenem HBr to potentially be
the first oral broad-spectrum carbapenem in the U.S. for use in
patients with cUTI. Oral administration may provide physicians with
an alternative to hospital-based IV therapy, for appropriate
patients, with potential value to the broader 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.
Patients are being randomized 1:1 to receive tebipenem HBr
(600 mg) orally every six hours, or imipenem cilastatin
(500 mg) IV every six hours, for a total of seven to ten days.
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. The trial
is designed to enroll approximately 2,648 patients, with
randomization stratified by age, baseline diagnosis (cUTI or AP),
and the presence or absence of urinary tract instrumentation. For
further details on the trial, refer to clinicaltrials.gov
identifier NCT06059846.
The FDA has indicated that positive and
persuasive results from PIVOT-PO, supported with confirmatory
evidence of efficacy, could be sufficient to support approval of
tebipenem HBr as a treatment for cUTI, including pyelonephritis,
for a limited use indication.
Under the terms of its license agreement with
GSK, Spero is also eligible to receive the following
milestone/royalty payments: (1) an additional $25 million in
development milestones; (2) up to $150 million in potential
commercial milestones based on first commercial sale; (3) up to
$225 million in potential sales-based milestones; and (4)
low-single digit to low-double digit tiered royalties on net
product sales of tebipenem HBr in all territories, except Japan and
certain other Asian countries. Additional information on the
license agreement is available here.
About Tebipenem HBr
Tebipenem HBr (tebipenem pivoxil hydrobromide;
formerly SPR994) is Spero’s novel late-stage development asset, an
oral formulation of tebipenem pivoxil, a carbapenem antibiotic of
the β-lactam class 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 subclass of antibiotics
because they have been observed to be safe and effective 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 may 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 US
Food and Drug Administration (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 U.S. 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, and the
potential receipt under the GSK license agreement of milestone
payments and royalties on future sales of tebipenem HBr. 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
FinanceIR@sperotherapeutics.com(617) 798-4039
Media Inquiries: Lora Grassilli, Health Media
RelationsZeno Grouplora.grassilli@zenogroup.com646-932-3735
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