Benzinga | Jan 19, 2022 08:07AM EST

Spero Therapeutics Wins Up To Added $12.9M By Biomedical Advanced R&D Authority (BARDA) To Support Development Of Orally Administered Tebipenem Pivoxil In Pediatric Patients

Spero Therapeutics, Inc. (NASDAQ:SPRO) today announced that the Company and the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, are expanding their existing partnership to develop tebipenem as a treatment for complicated urinary tract infections (cUTI), including pyelonephritis, in pediatric patients.



BARDA added, and exercised, a new option on the contract originally awarded to Spero in 2018. The new option increases the total amount of committed funding by $12.9M to $46.9M, increasing the total potential contract value to $59.7M. As previously announced, the Defense Threat Reduction Agency (DTRA) is providing up to approximately $10.0M, in addition to the total potential award from BARDA, to cover the cost of the nonclinical biodefense aspects of the collaboration program for tebipenem HBr. The additional $12.9M option is expected to provide support for a clinical trial and related activities for orally administered tebipenem pivoxil's use in treating pediatric patients with cUTI, including AP.

"We are pleased to expand our relationship with BARDA and look forward to continuing our productive collaboration," said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. "This new option award not only provides further external validation for tebipenem HBr and its robust clinical dataset, but also allows us to pursue development of tebipenem for use in pediatric patients with cUTI. We would like to thank BARDA for their continued collaboration, as we work to address oral alternatives to treat multi-drug resistant bacterial infections, providing therapeutic options to those adults and children with unmet needs."

Spero currently has a New Drug Application (NDA) seeking approval for tebipenem HBr oral tablets for treatment in adult patients with cUTI, including pyelonephritis, caused by susceptible microorganisms, under review by the United States Food and Drug Administration (FDA).

Tebipenem HBr Research Support

This project has 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.