Spero Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Tebipenem HBr New Drug Application
June 27 2022 - 3:05PM
Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced that
it has received a Complete Response Letter (CRL) from the U.S. Food
and Drug Administration (FDA) for its New Drug Application (NDA)
seeking approval for tebipenem HBr oral tablets for treatment of
adult patients with complicated urinary tract infection (cUTI),
including pyelonephritis. The FDA had set a Prescription Drug User
Fee Act (PDUFA) target action date of June 27, 2022.
In the CRL, the FDA communicated that it had
completed its review of the NDA and determined that the NDA could
not be approved in its present form. As previously disclosed in
Spero’s May 3, 2022 press release, the CRL was anticipated based on
feedback received at the late cycle meeting, in which the agency
outlined potential deficiencies in the application. In the CRL, the
FDA ultimately concluded that Spero’s Phase 3 cUTI study of
tebipenem HBr (ADAPT-PO) was insufficient to support approval and
that additional clinical study would be required. Spero intends to
promptly request a Type A meeting with the FDA, to gain further
insights as to the pathway forward towards a potential regulatory
approval for tebipenem HBr.
“We are disappointed with the FDA’s decision,
but we look forward to our continued dialogue, addressing the
agency’s concerns and outlining a clear path forward for tebipenem
HBr,” said Ankit Mahadevia, M.D., Chief Executive Officer
of Spero Therapeutics. “With this development, we continue to
believe that tebipenem HBr offers patients and their providers an
important new treatment option, that if approved, has the potential
to address the critical unmet need for a new oral antibiotic for
patients with cUTI.”
Dr. Mahadevia continued, “Our commitment to the
development of effective new agents to address unmet medical needs
remains strong, as we seek to identify the optimal path forward for
tebipenem’s regulatory approval, commercialization, and value
creation, potentially through external partnerships. Tebipenem HBr
remains an important part of the Spero pipeline and a complement to
our SPR720 and SPR206 programs, which we continue to advance
towards key clinical and regulatory milestones.”
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 Assistant Secretary for
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 tebipenem HBr, SPR206 and SPR720; 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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