Spero Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Tebipenem HBr for Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis

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CAMBRIDGE, Mass., January 03, 2022 (GLOBE NEWSWIRE) – Spero Therapeutics, Inc. (NASDAQ: SPRO), today announced that the United States Food and Drug Administration (FDA) has granted the review designation priority and confirmed acceptance of the New Drug Application Review (NDA) for approval of oral tebipenem HBr tablets for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis acute, caused by susceptible microorganisms. Tebipenem HBr has received Qualified Infectious Disease Product (QIDP), Fast Track and Priority Review designations for these cUTI indications. The Agency plans to hold an advisory committee meeting to discuss this request and has also set a target date for action under the Prescription Drug User Fees Act (PDUFA) of June 27, 2022.

“FDA acceptance of this NDA is an important step in our mission to provide patients with the first and only oral carbapenem antibiotic to treat UTI. If approved, tebipenem HBr may offer patients an oral treatment option, potentially allowing them to recover at home from their infections or to be discharged from the hospital earlier, ”said Ankit Mahadevia, MD, CEO by Spero. “This is a significant achievement and an exciting time for all of us at Spero as we execute on our plan to become a commercial organization. We are committed to working closely with the FDA throughout the NDA review process and look forward to the planned launch of tebipenem HBr in the second half of 2022. “

The NDA submission includes previously reported positive data from the ADAPT-PO Phase 3 trial. These data showed that ADAPT-PO met its primary endpoint by demonstrating that oral HBr tebipenem was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with acute pyelonephritis (AP).

David Melnick, MD, Medical Director of Spero, added, “ADAPT-PO has been rigorously designed both to support this NDA and to provide physicians with the confidence to prescribe oral tebipenem HBr to appropriate patients instead. IV treatment, if approved. We believe that the positive results of the trial have enabled us to achieve this first goal and indicate that the use of tebipenem HBr may ultimately improve patient care and reduce the use of healthcare resources in the UTI. “

About Spéro Therapeutic
Spero Therapeutics, Inc. is a clinical-stage, multi-active biopharmaceutical company focused on the identification, development and commercialization of novel treatments for multidrug-resistant bacterial infections (MDR) and rare diseases.

Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is in development as the first oral carbapenem antibiotic for use in cTIs, including pyelonephritis. Tebipenem HBr is an investigational drug in the United States and is not currently approved for the treatment of complicated urinary tract infections, including pyelonephritis.

Spero is also developing SPR720 as a new oral therapy product candidate for the treatment of rare orphan lung disease caused by non-tuberculous mycobacterial infections.

Spero also has a next-generation, intravenously administered polymyxin product candidate, SPR206, developed from its potentiation platform, which is under development to treat Gram-negative MDR infections in hospital settings.

For more information visit https://sperotherapeutics.com.

Forward-looking statements
This press release may contain forward-looking statements. These statements include, but are not limited to, statements regarding the potential approval of tebipenem HBr by the FDA; the timing of the initiation of tebipenem HBr; the potential number of patients who could be treated with tebipenem HBr and the market demand for tebipenem HBr in general; the efficacy of tebipenem HBr and its potential impact on the use of health resources; the intended change from intravenous to oral administration and the length of time Spero should have sufficient liquidity. In some cases, forward-looking statements may be identified by words such as “may”, “will”, “should”, “expect”, “plan”, “aim”, “anticipate”, “may”, “Could”, “intention,” “target”, “plan”, “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 these forward-looking statements due to various material factors, including any delay in the consideration of the NDA submission by the FDA for any reason or as of date. PDUFA for the NDA review may be revised; including the COVID-19 pandemic; the timing and content of advice given and decisions made by regulators, including the FDA; Spero’s need for additional funding; the long, expensive and uncertain process of clinical drug development; if the results states obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero’s dependence on third parties to manufacture, develop and market its product candidates, if approved; the ability to develop and market Spero’s product candidates, if approved; the potential impact of the COVID-19 pandemic; Spero’s ability to retain key personnel and manage its growth; whether Spero’s cash resources will be sufficient to finance its continuing operations for the periods and / or tests planned; and other factors discussed in “Risk Factors” set out in documents Spero makes periodically with the United States Securities and Exchange Commission. The forward-looking statements included in this press release represent the views of Spero as of the date of this press release. Spero expects subsequent events and developments to change his views. However, although Spero may choose to update these forward-looking statements at some time in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be taken as representing the views of Spero as of any date subsequent to the date of this press release.

Investor Relations Contact:
Ted jenkins
Vice-President, Investor Relations and Specialized Finance
[email protected]
(617) 798-4039

Media contact:
Jacqueline Pomfret Kirby
Vice-President, Corporate Affairs
[email protected]
(617) 798-4074

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