Spero Therapeutics, Inc., a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections and rare diseases, announced that it has received a $5.9 million award from the U.S. Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP) Joint Warfighter Medical Research Program (Award number W81XWH-19-1-0295). The U.S. Army Medical Research Acquisition Activity, 839 Chandler Street, Fort Detrick MD 21702- 5014 is the awarding and administering acquisition office.
The funding will support the further clinical development of SPR206, Spero’s intravenous (IV)-administered product candidate from its Potentiator Platform that is being developed as an innovative alternative option to treat MDR Gram-negative bacterial infections. The award commits non-dilutive funding of $5.9 million over a four-year period to cover the costs of select Phase 1 pharmacology studies, a 28-day GLP non-human primate toxicology study, and microbiological surveillance studies that would be required for a potential New Drug Application (NDA) submission with the U.S. Food and Drug Administration for SPR206.
In preclinical studies, SPR206 has demonstrated activity as a single agent against MDR and extensively drug resistant (XDR) bacterial strains, including isolates of Pseudomonas aeruginosa, Acinetobacter baumannii and carbapenem-resistant Enterobacteriaceae, in both in vitro and in vivo models of infection. SPR206 is currently being evaluated in a first-in-human Phase 1 clinical trial, designed as a double-blind, placebo-controlled, single and multiple ascending dose, multi-cohort study in healthy subjects. Spero expects to report top-line data from this trial in the second half of 2019. “
Spero is dedicated to fighting emerging drug-resistant infections and tackling this critical problem that faces our civilian and military populations alike,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. “We are honored to be selected for this award, which will enable us to advance the clinical development of SPR206 using non-dilutive funding, and we look forward to strengthening our existing relationship with the Department of Defense.”
The DoD recognizes the need for safe, novel antibiotics effective against MDR organisms that can cause hospital or community-associated infections in veterans or combat wound infections in active duty military personnel.
About the Spero Potentiator Platform – SPR206
Spero’s Potentiator Platform molecules are designed to treat Gram-negative bacterial infections through the molecule’s interactions with the bacterium’s outer membrane. The Potentiator Platform molecules exhibit this effect as a monotherapy or by co-administration with existing antibiotics. Spero currently has two Potentiator Platform drug candidates – SPR206, a direct acting IV-administered agent that has demonstrated broad Gram-negative antibacterial activity. SPR206 is designed to have antibiotic activity as a single agent against MDR and XDR bacterial strains, including carbapenem-resistant Pseudomonas aeruginosa, Acinetobacter baumannii and Enterobacteriaceae. Spero initiated a Phase 1 trial of SPR206 in December 2018 and anticipates top-line data from the trial in the second half of 2019. Spero believes that its current intellectual property portfolio and pending patent applications will provide global protection, including China, the United States and Europe for SPR206 Spero believes that its current intellectual property portfolio and pending patent applications will provide global protection, including China, the United States and Europe for SPR206 through 2039 and 2038, respectively.