Spero Therapeutics Awarded up to an Additional $12.9 Million by BARDA to Support the Development of Orally Administered Tebipenem Pivoxil in Pediatric Patients

Spero Therapeutics, Inc. recently announced 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 US 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, MD, 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 US FDA.

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.

Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug-resistant (MDR) bacterial infections and rare diseases. Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in cUTI, including pyelonephritis. On January 3, 2022, Spero announced that FDA has accepted its NDA for tebipenem HBr tablets.

Tebipenem HBr is an investigational drug in the United States and is currently not approved for the treatment of complicated urinary tract infection, including pyelonephritis. Spero is also developing SPR720 as a novel oral therapy product candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.

Spero also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is being developed to treat MDR Gram-negative infections in the hospital setting. For more information, visit https://sperotherapeutics.com.