FDA identifies deficiencies in NDA for tebipenem HBr and ADAPT-PO trial.
Spero Therapeutics, Inc. announced that it will immediately defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting (LCM) with the FDA regarding Spero’s New Drug Application (NDA) for tebipenem HBr.
Although the review is still ongoing and the FDA has not yet made any final determination regarding approvability, the discussion suggested that the data package may be insufficient to support approval during this review cycle.
In evaluating the efficacy of tebipenem HBr in the Phase III (ADAPT-PO) cUTI study, the FDA conducted a separate analysis of the microbiological intent-to-treat (micro-ITT) population, relative to the prespecified analysis as set forth in the previously submitted and reviewed protocol and statistical analysis plan for ADAPT-PO. The effect of this new analysis was to reduce the number of evaluable patients in the primary analysis population compared with those resulting from the trial’s pre-specified micro-ITT population as outlined in the statistical analysis plan. As a result, the FDA considers that the pre-specified non-inferiority (NI) margin of -12.5% was not met. Spero is continuing its dialogue with the FDA, as the company seeks a pathway forward for potential approval of tebipenem HBr.
In connection with this development, Spero announced that it is undertaking a reduction in its workforce by approximately 75% and a restructuring of its operations to reduce operating costs and reallocate resources towards the clinical development programs of SPR720 and SPR206, while continuing engagement with the FDA on the appropriate path forward for tebipenem HBr. Based on the anticipated cost-savings of this restructuring and other assumptions, Spero anticipates it will be able to fund its planned operating expenses and capital expenditure requirements pursuant to the priorities of its strategic refocusing through late 2023.
In April 7, 2022, The New England Journal of Medicine published the results from the Phase III ADAPT-PO clinical trial, whose topline results Spero originally reported in September 2020.
See- "Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection."-Paul B. Eckburg, M.D., Lori Muir, B.Sc., Ian A. Critchley, Ph.D., Susannah Walpole, Ph.D., et, al., :April 7, 2022 N Engl J Med 2022; 386:1327-1338. DOI: 10.1056/NEJMoa2105462.
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