Spero Therapeutics Provides Tebipenem HBr Program Update Following Type A Meeting with the U.S. Food and Drug Administration
September 06 2022 - 8:05AM
Spero Therapeutics, Inc. (Nasdaq: SPRO) today provided an
update on its tebipenem HBr program following the receipt of
minutes from a recent Type A meeting with the U.S. Food and Drug
Administration (FDA), discussing steps required for resubmission of
the New Drug Application (NDA) for tebipenem HBr for the treatment
of complicated urinary tract infection (cUTI), including
pyelonephritis.
During the Type A meeting, the FDA indicated
that positive results from a single additional Phase 3 clinical
trial supported by confirmatory nonclinical evidence of efficacy
could be sufficient to support the approval of tebipenem HBr for
the treatment of cUTI, including pyelonephritis for a limited use
indication. Spero and the FDA also achieved alignment on key
components of the proposed pivotal Phase 3 trial design which may
be the subject of a Special Protocol Assessment (SPA) request, to
be confirmed once the clinical protocol is finalized.
“We are pleased to have found common ground with
the FDA on the regulatory path forward for tebipenem HBr,” said
Ankit Mahadevia, M.D., Chief Executive Officer of Spero
Therapeutics. “With this clarity, we are better positioned to
advance the program as we work to establish and nurture external
partnerships for further development. The pivotal Phase 3 trial is
supported by an extensive clinical and nonclinical data package
demonstrating the potential of tebipenem HBr to provide cUTI
patients with an oral alternative to intravenous therapy; an option
that we believe solidifies tebipenem HBr as a significant source of
potential value that complements our lead SPR720, and partnership
directed SPR206 programs.”
As previously reported, Spero received a
Complete Response Letter (CRL) from the FDA in June 2022 for a
prior NDA seeking approval for tebipenem HBr for the treatment of
adult patients with certain bacterial microorganisms that cause
cUTI, including pyelonephritis. In the CRL, the FDA concluded that
data from Spero’s prior Phase 3 cUTI clinical trial, ADAPT-PO, were
insufficient to support approval during the prior review cycle.
Spero plans to advance tebipenem HBr’s clinical development and
potential commercialization through external partnership, and if
approved, tebipenem HBr would be the first oral carbapenem
antibiotic to receive marketing approval in the United States.
Tebipenem HBr Research
SupportSelect tebipenem HBr studies have been funded in
part with federal funds from the Department of Health and Human
Services; Office of the Administration for Strategic Preparedness
and Response; Biomedical Advanced Research and Development
Authority, under contract number HHSO100201800015C.
About Spero TherapeuticsSpero
Therapeutics 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.
- Spero Therapeutics also has an
IV-administered next generation polymyxin product candidate,
SPR206, developed from its potentiator platform, which is in
development to treat multi-drug resistant Gram-negative infections
in the hospital setting.
- Tebipenem HBr is an investigational
drug in the United States being developed for the treatment of
cUTI, including pyelonephritis, caused by certain microorganisms,
in adult patients who have limited treatment options; tebipenem HBr
is not FDA-approved.
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
potential regulatory path forward for tebipenem HBr and the
potential approval of tebipenem HBr by the FDA and the timing
thereof; the potential value of tebipenem HBr; the potential for a
partnership of the tebipenem HBr franchise; the future development
and commercialization of SPR720, SPR206, and tebipenem HBr; the
design, initiation, timing, progress and results of Spero’s
preclinical studies and clinical trials and its research and
development programs; and management’s assessment of the results of
such preclinical studies and clinical trials. 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 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 add costs for Spero, delay approval and/or reduce the
commercial prospects of tebipenem HBr; whether any third parties
would be interested in partnering with Spero to pursue continued
efforts to obtain FDA approval of tebipenem HBr, or acquiring
rights to the tebipenem HBr program from Spero through a
partnership arrangement; the COVID-19 pandemic; Spero’s need for
additional funding; the risk that Spero may not be able to address
the FDA's concerns with respect to tebipenem HBr; the lengthy,
expensive, and uncertain process of clinical drug development for
SPR720 and SPR206; 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; the ability to commercialize Spero’s product candidates,
if approved; Spero’s ability to retain key personnel; 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
FinanceTJenkins@sperotherapeutics.com (617) 798-4039
Media Inquiries:
media@sperotherapeutics.com
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