Collaboration Among BARDA, DTRA, USAMRIID and Spero to Advance SPR994

Medical Countermeasure DevelopmentSpero Therapeutics, Inc. today announced that it was awarded funding of $15.7 million, with the potential for up to an additional $28.5 million over 5 years, from the Biomedical Advanced Research and Development Authority (BARDA).

The funding will support the further clinical development of Spero’s oral carbapenem product candidate, SPR994, for the treatment of complicated urinary tract infections (cUTIs) caused by antibiotic resistant Gram-negative bacteria. As part of the inter-agency collaboration with Spero, a series of studies to assess the efficacy of SPR994 in the treatment of infections caused by biodefense threats such as anthrax, plague and melioidosis will be conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).

In addition, the Defense Threat Reduction Agency (DTRA) will provide support up to $10 million to fund the nonclinical biodefense aspects of the inter-agency collaboration. The collaboration may also include a clinical trial in pneumonia patients, an indication for which tebipenem, SPR994’s active pharmaceutical ingredient, is currently approved in Japan for pediatric use.

Together, the two agencies will provide up to $54.2 million in total funding for the clinical development and biodefense assessment of SPR994, a portion of which is subject to the exercise of options by BARDA and Spero’s achievement of specified milestones.

“We are honored to be the recipient of an award and to join BARDA and DTRA in this unique inter-agency collaboration. We look forward to advancing SPR994 through clinical development for public and biodefense use as we target public health needs caused by emerging drug-resistant infections,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “We believe the funding is a validation of the clinical potential of SPR994 across a broad treatment landscape, and of the ability of a small biotech company to work towards bringing these innovative therapies to patients in collaboration with our partners at BARDA and DTRA.”

The award from BARDA commits $15.7 million of guaranteed initial funding and up to an additional $28.5 million over 5 years if BARDA exercises all of its options under the award.  Additionally, DTRA will commit  $1.25 million of initial support, and up to an additional $8.75 million upon the achievement of specified milestones.

In preclinical studies, SPR994 has shown potent antibiotic activity against Gram-negative bacteria, including E. coli-producing extended-spectrum beta-lactamases (ESBLs) and ESBL-producing Klebsiella pneumoniae, similar to IV-administered ertapenem. Approximately 1,200 subjects have been dosed with tebipenem in clinical and pharmacologic studies conducted by Meiji during its development of tebipenem in Japan.  In addition, available post-marketing outcomes data report the safety and efficacy of tebipenem in 3,540 pediatric patients with pneumonia, otitis media or sinusitis, and these data are consistent with the safety profile of tebipenem as observed in the clinical trial conducted by Meiji.

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